Compositions and methods for male contraception

Abstract

The disclosure provides for compositions for the contraceptive treatment of males, comprising a first compound, wherein the first compound comprises testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof, and a second compound, wherein the second compound comprises segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof.

Description

COMPOSITIONS AND METHODS FOR MALE CONTRACEPTIONCROSS-REFERENCE TO RELATED APPLICATIONSThe present application claims priority to US Provisional Patent Application No. 63 / 693,464 filed September 11, 2024, herein incorporated by reference in its entirety.BACKGROUND

[0001] Contraceptive usage has increased globally, yet 40-45% of pregnancies are unintended. In the United States alone, mistimed, unplanned or unwanted pregnancies result in a total public expenditure of $21 billion per year. Many of these pregnancies are considered high-risk with evidence that both the women and the children experience worse health outcomes than intended pregnancies. Popular contraceptive methods include male / female condoms, female hormone treatments (pills, patches, implants, etc.), and intrauterine devices. Over the past three decades, even though many effective female contraceptive options have been introduced to market, unintended pregnancy rates have remained relatively constant. Furthermore, most contraception methods are directed towards females, such as birth control pills, intrauterine devices (IUDs), and birth control implants. Many of these interventions come with the risk of a plethora of adverse side effects, which can affect the quality of life of the users, decrease subject adherence with the intervention, and can deter others from possible use. The use of male / female condoms has proved to have many downfalls, such as incorrect use and non-adherence. Many other contraceptive methods, such as vasectomies, require surgical intervention, to which many subjects are deterred. Accordingly, there is a need for additional contraceptive methods, especially those directed for use by males and preferably those that have a decreased incidence of adverse events. A promising strategy to reduce the number of unintended pregnancies and the subsequent societal and family costs is to increase contraceptive options, specifically options available to men.INCORPORATION BY REFERENCE

[0002] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.SUMMARY

[0003] Disclosed in certain embodiments herein are compositions for contraceptive treatment of males, comprising: a) a first compound, wherein the first compound comprises testosterone, aderivative thereof, or a pharmaceutically acceptable salt thereof, and b) a second compound, wherein the second compound comprises segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof, wherein the composition is a non-topical composition. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is naturally-derived. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is synthetic. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg to about 200 mg. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 73.8 mg. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 36.39 mg. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg / mL to about 25 mg / mL. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 10 mg / mL to about 20 mg / mL. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 0.5% to about 4% wt / wt. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.6% wt / wt. In some embodiments, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.697% wt / wt. In some embodiments, the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.7% wt / wt. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is naturally-derived. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is synthetic. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1 mg to about 200 mg. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is about 8.2 mg. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is about 4.1 mg. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg / mL to about 4 mg / mL. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg / mL to about 2 mg / mL. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about0.01% to about 0.5% wt / wt. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.1% wt / wt. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.19% wt / wt. In some embodiments, the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.2% wt / wt. In some embodiments, the non-topical composition is formulated into a solution, liquid suspension, a lotion, a gel, a paste, a shampoo, a scrub, a rub, a smear, a medicated stick, a medicated bandage, or a cream. In some embodiments, the non- topical composition is formulated as an injectable composition, an oral composition, an inhalable composition, an intranasal composition, or a sublingual composition. In some embodiments, the composition is the injectable composition. In some embodiments, the composition is in a liquid dosage form. In some embodiments, the injectable composition is formulated for intramuscular, intravenous, subcutaneous, intraosseous, or intradermal injection. In some embodiments, the composition is the oral composition or the sublingual. In some embodiments, the composition is in a gel dosage form. In some embodiments, the gel dosage form is formulated for intranasal delivery. In some embodiments, the composition is in a solid dosage form. In some embodiments, the composition is in the form of a pill. In some embodiments, the composition is in the form of a powder. In some embodiments, the powder is designed as an additive to a food or a drink. In some embodiments, the composition is in the form of a gum, paste or liquid. In some embodiments, the composition is the inhalable composition. In some embodiments, the composition is a liquid suspension or solution. In some embodiments, the inhalable composition is nebulized. In some embodiments, the inhalable composition is in a gaseous dosage form. In some embodiments, the inhalable composition is formulated for inhalation by mouth. In some embodiments, the inhalable composition is formulated for nasal inhalation. In some embodiments, the composition is implantable. In some embodiments, the composition is formulated in a subdermal implant. In some embodiments, the subdermal implant comprises a polymer. In some embodiments, the polymer is biodegradable. In some embodiments, the polymer is not biodegradable. In some embodiments, the composition is delivered intranasally, for example, as a gel. In some embodiments, the composition further comprises a therapeutic agent. In some embodiments, the therapeutic agent is a contraceptive. In some embodiments, the therapeutic agent is a spermicide. In some embodiments, the therapeutic agent is for use in treating a sexually-transmitted disease (STD). In some embodiments, the therapeutic agent is for use in preventing a STD. In some embodiments, the STD is gonorrhea, syphilis, trichomoniasis, pelvic inflammatory disease, lymphogranuloma venereum,mycoplasma genitalium, bacterial vaginosis, or chlamydia. In some embodiments, the STD is human immunodeficiency virus (HIV), herpes, genital herpes, hepatitis B, viral hepatitis, human papillomavirus (HPV), molluscum contagiosum virus (MCV), or zika virus. In some embodiments, the STD is scabies or public lice. In some embodiments, the therapeutic agent is an antiviral. In some embodiments, the therapeutic agent is an antibiotic. In some embodiments, the therapeutic agent is an antibody. In some embodiments, the therapeutic agent is a compound. In some embodiments, the composition further comprises a pharmaceutically acceptable excipient. In some embodiments, the composition further comprises a taste-masking additive. In some embodiments, the composition further comprises an aroma compound. In some embodiments, the composition is formulated for daily use, twice daily use, weekly use, twice weekly use, use every other day, use every two days, monthly use, or yearly use. In some embodiments, the first compound and the second compound are formulated as a single composition. In some embodiments, the first compound and the second compound are formulated as separate compositions.

[0004] Also disclosed herein are methods for contraceptive treatment of males, the method comprising administering to a subject in need thereof any composition as described herein. Also disclosed herein are methods for treating acne, the method comprising administering to a subject in need thereof any composition as described herein. Also disclosed herein are methods for treating sexual dysfunction, the method comprising administering to a subject in need thereof any composition as described herein. Also disclosed herein are methods for increasing libido, the method comprising administering to a subject in need thereof any composition as described herein. In some embodiments, the administering does not affect serum testosterone levels in the subject. In some embodiments, serum testosterone levels in the subject are maintained at a concentration of about 300 nanograms per deciliter (ng / dL) to about 1,000 ng / dL. In some embodiments, serum testosterone concentration in the subject is maintained between about 400 and 1050 ng testosterone per dL serum. In some embodiments, the serum testosterone concentration is maintained between about 200 and 1800 ng testosterone per dL serum. In some embodiments, serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after the administering and ending about 24 hours after the administering. In some embodiments, serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after the administering and ending about 48 hours after the administering. In some embodiments, serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after theadministering and ending about 72 hours after the administering. In some embodiments, the administering suppresses luteinizing hormone (LH) in the subject. In some embodiments, the administering suppresses follicle stimulating hormone (FSH) in the subject. In some embodiments, the administering decreases endogenous testosterone secretion in testes of the subject. In some embodiments, the administering decreases the incidence of acne of a subject by at least about 10%, 20%, 30%, 40%, 50% as compared to a subject not having the composition or having a composition comprising a lower dose of testosterone. In some embodiments, the effects of the composition are reversible within a week, a month, 3 months, 6 months, or 1 year after halting administration of the composition to the subject. In some embodiments, the first compound and the second compound are administered to the subject as a single composition or a separate composition. In some embodiments, the first compound and the second compound are administered to the subject simultaneously or sequentially. In some embodiments, the administering to the subject is once, twice, or three times daily for at least 5 days. In some embodiments, the administering to the subject is once, twice, three or four times per month for at least 5 months.

[0005] Also disclosed herein are kits comprising any composition as described herein and instructions for use and methods and uses of the compositions and / or kits.DETAILED DESCRIPTION

[0006] Approximately 45% of pregnancies worldwide are unintended, which contribute to undesirable health problems including maternal morbidity and mortality, and significant societal burden. Despite many contraceptive methods available for use by women, male contraceptive methods are limited to withdrawal, condom, and vasectomy. Condom use suffers from inconsistent and improper use, and a use failure rate of 13%, whereas vasectomy requires surgery and is not easily and reliably reversible.

[0007] Provided herein are compositions, methods, and kits for reversible male contraception by administering to a subject in need thereof a composition, the composition comprising testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof, and segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof.

[0008] While various embodiments of the invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions may occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed.

[0009] Definitions

[0010] In the following description, certain specific details are set forth in order to provide a thorough understanding of various embodiments. However, one skilled in the art will understand that the invention may be practiced without these details. In other instances, well- known structures have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments. Unless the context requires otherwise, throughout the specification and claims which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense, that is, as “including, but not limited to.” Further, headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed invention.

[0011] As used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise. Thus, for example, reference to “an excipient” is a reference to one or more excipients and equivalents thereof known to those skilled in the art, and so forth.

[0012] The use of the term “or” in the claims is used to mean “and / or” unless explicitly indicated to refer to alternatives only or the alternatives are mutually exclusive, although the disclosure supports a definition that refers to only alternatives and to “and / or ”

[0013] Reference throughout this specification to “some embodiments” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0014] An “effective amount” or “therapeutically effective amount” refers to an amount of a compound administered to a subject, either as a single dose or as part of a series of doses, which is effective to produce a desired therapeutic effect.

[0015] As used herein, the term “contraceptive agent” can refer to medications administered in order to prevent or reduce the likelihood of pregnancy. As used herein, the term “contraceptive agent” can alternatively or additionally refer to medications that reduce sperm concentration and / or motility. A “contraceptive agent” disclosed herein may refer to one contraceptive agent, or a combination of two or more contraceptive agents.

[0016] As used herein, an “excipient” refers to a substance that is added to a composition to provide, without limitation, bulk, consistency, stability, binding ability, lubrication, disintegratingability, etc., to the composition. A “diluent” is a type of excipient and refers to an ingredient in a pharmaceutical composition that lacks pharmacological activity but may be pharmaceutically necessary or desirable. For example, a diluent may be used to increase the bulk of a potent drug whose mass is too small for manufacture and / or administration. It may also be a liquid for the dissolution of a drug to be administered by injection, ingestion, or inhalation. A pharmaceutically acceptable excipient is a physiologically and pharmaceutically suitable nontoxic and inactive material or ingredient that does not interfere with the activity of the drug substance.Pharmaceutically acceptable excipients are well known in the pharmaceutical art and described, for example, in Rowe et al., Handbook of Pharmaceutical Excipients: A Comprehensive Guide to Uses, Properties, and Safety, 5th Ed., 2006, and in Remington: The Science and Practice of Pharmacy (Gennaro, 21st Ed. Mack Pub. Co., Easton, PA (2005)). Preservatives, stabilizers, dyes, buffers, and the like may be provided in the pharmaceutical composition. In addition, antioxidants and suspending agents may also be used. For compositions formulated as liquid solutions, acceptable carriers and / or diluents include saline and sterile water, and may optionally include antioxidants, buffers, bacteriostats and other common additives. In some embodiments, the diluents may be a buffered aqueous solution such as, without limitation, phosphate buffered saline. The compositions may also be formulated as capsules, granules, or tablets which contain, in addition to a compound as disclosed and described herein, diluents, dispersing and surface-active agents, binders, and lubricants. One skilled in this art may further formulate a compound as disclosed and described herein in an appropriate manner, and in accordance with accepted practices, such as those disclosed in Remington, supra.

[0017] The term contraceptive in reference to “treat,” “treatment,” or “therapy” as used herein refers to the administration of the present composition in order to achieve prevention or reduction the likelihood of pregnancy.

[0018] Unless specifically stated or obvious from context, as used herein, the term “about” in reference to a number or range of numbers is understood to mean the stated number and numbers + / - 10% thereof, or 10% below the lower listed limit and 10% above the higher listed limit for the values listed for a range. The term also includes more specific values of ± 5%, ± 2% and ± 1% of the stated value.

[0019] Whenever the term “at least,” “greater than,” or “greater than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “at least,” “greater than” or “greater than or equal to” applies to each of the numerical values in that series of numerical values. For example, greater than or equal to 1, 2, or 3 is equivalent to greater than or equal to 1, greater than or equal to 2, or greater than or equal to 3.

[0020] Whenever the term “no more than,” “less than,” or “less than or equal to” precedes the first numerical value in a series of two or more numerical values, the term “no more than,” “less than,” or “less than or equal to” applies to each of the numerical values in that series of numerical values. For example, less than or equal to 3, 2, or 1 is equivalent to less than or equal to 3, less than or equal to 2, or less than or equal to 1.

[0021] Compounds

[0022] Described herein are compositions of testosterone or a pharmaceutically acceptable salt thereof. Testosterone is a male sex hormone that is produced in the testicles. Testosterone hormone levels are important to normal male sexual development and function. For example, testosterone is required for sperm production and spermatogenesis. In some embodiments, testosterone is naturally occurring. Alternatively, in some embodiments, testosterone is synthetic. Testosterone has a molecular formula of C19H28O2 and a structure ofTestosterone

[0023] Described herein are compositions of testosterone derivatives or a pharmaceutically acceptable salt thereof. In some embodiments, testosterone derivatives are naturally occurring. Alternatively, in some embodiments, testosterone derivatives are synthetic. In some embodiments, a testosterone derivative as described herein can be biologically active. In some embodiments, a testosterone derivative as described herein can be a prodrug, which needs to be metabolized to become an active compound. Non-limiting examples of testosterone derivatives can include dihydrotestosterone, 5-a-dihydrotestosterone, testosterone undecanoate, 19- nortestosterone, 7-a-methyl-19-nortestosterone, 11 -m ethyl- 19-nortestosterone, testosterone enanthate, 19-nor-59-testosterone, 7cc, 1 ip-dimethyl- 19-nortestosterone, testosterone propionate, 4-chloro- 19-nortestosterone, 4-hydroxy- 19-nortestosterone, 19-nor-89,l 1 -testosterone, 7a- methyl- 19-nortestosterone, 4-hydroxytestosterone, 11 -ketotestosterone, 17a-alkylated testosterone, methyltestosterone, ethyltestosterone, 17a-ethynylated testosterone, 17a-vinylated testosterone, ethylnyltestosterone, vinyltestosterone, l -testosterone, 4-androstenediol, 4- dehydroepiandrosterone, 5-androstenedione, 5-dehydroandrosterone, 1 ip-hydroxy-4- androstenedione, 1 l-keto-4-androstenedione, 5-androstenediol, 4-androstenedione, 1-methyl- 81-4-androstenedione, 31 -4-androstenedione, 5-dehydroepiandrosterone, 6-methylidene-81-4-androstenedione, 4-hydroxy-4-androstenedione, testosterone 17-chloral hemiacetal ether, Al- testosterone 17p-cyclopentenyl enol ether, testosterone, testosterone enanthate, testosterone cypionate, testosterone ester, testosterone undecanoate, testosterone propionate, testosterone 17P-trimethylsilyl ether, 10-propargyl-4-androstenedione, 4,5a-dihydrotestosterone, 4,5a- dihydro-81 -testosterone, 1 l-keto-4,5a-dihydrotestosterone, 2a-methyl-4,5a- dihydrotestosterone, 2a,3a-epithio-3 -deketo- 4,5a-dihydrotestosterone, la-methyl-4,5a- dihydrotestosterone, l-methyl-4,5a-dihydro-81- testosterone, 2a-chl oro-4, 5 a- dihydrotestosterone 3-O-(p-nitrophenyl)oxime, 2-methyl-4,5a-dihydro-81-testosterone, 1- dehydroepiandrosterone, 1-androstenediol (4,5a-dihydro-81-4-androstenediol), 1- androstenedione (4,5a-dihydro-81-4-androstenedione), 3-deketo-2-androstenedione (3-deketo- 4,5a-dihydro-82-4-androstenedione), androsterone, epiandrosterone, 2a,3a-epithio-3-deketo- 4,5a-dihydrotestosterone 17p~(l -methoxy cyclopentane) ether, 4,5a-dihydro-81 -testosterone 17P-(1 -methoxy cyclohexane) ether, 2'H-5a-androst-2-eno[3,2-c]pyrazol-17P-ol 17P- tetrahydropyran ether, 3,3-[(lE,2E)-l,2-hydrazinediylidene]di(2a-methyl-5a-androstan-17P- ol), 4-chlorotestosterone, 7a-methyl-19-nor-4-androstenedione, 19-nor-5-androstenediol, 19- nor-5-androstenedione, 19-nor-5-dehydroepiandrosterone, 19-nor-4-androstenediol, 19-nor-4- androstenedione, 19-nor-89-4-androstenedione, 18-methyl-19-nor-82,5(10)-epiandrosterone 3- methyl ether, 19-nor-89,l 1-4-androstenedione, 19-nortestosterone 17P-adamantoate, 7a, 17a- dimethyltestosterone, 7p,17a-dimethyltestosterone, 4-chloro-17a-methyl-81 -testosterone, 4- hydroxy-17a-methyl-81-testosterone, 17a-ethyltestosterone, 17a-methyl-81 -testosterone, 9a- fluoro-1 ip-hydroxy-17a-methyltestosterone, 4-chloro-17a-m ethyltestosterone, 2-formyl-l la- hydroxy-17a-methyl-81-testosterone, 17a-m ethyltestosterone, 17a-methyl-2'H-androsta-2,4- dieno[3,2-c]pyrazol-17P-ol, 4-hydroxy-17a-methyltestosterone, la,7a-diacetylthio-17a- methyltestosterone, 4-chloro-17a-methyl-81-4-androstenediol, 4-chloro-17a-methyl-4- androstenediol, 17a-methyl-5-androstenediol, 17a-methyl-4-hydro-83,5-testosterone 3-hexyl ether, 17a-methyl-4-hydro-83,5-testosterone 3-cyclopentyl ether, 17a-methyl-5a- androstano[3,2-c]isoxazol-17P-ol, 3-deketo-17a-methyl-4,5a-dihydro-82 -testosterone, 7 a, 17a- dimethyl-19-nor-89,l 1 -testosterone, 17a-methyl-5a-androstano[2,3-c][l,2,5]oxadiazol-17P-ol, 17a-methyl-4,5a-dihydrotestosterone, 2a, 17a-dimethyl-4,5a-dihydrotestosterone, 17a-methyl- 4,5a-dihydro-81 -testosterone, 3 -azi- 17a-methyl-4, 5a-dihydrotestosterone, 7a, 17a-dimethyl- 19- nor-89-testosterone, 2a,3a-epithio-3-deketo-17a-methyl-4,5a-dihydrotestosterone, 17a-ethyl- 19-nor-89-testosterone, 2, 17a-dimethyl-4,5a-dihydro-81 -testosterone, 2-oxa-l 7a-methyl-4,5a- dihydrotestosterone, 2-hydroxymethylene-4,5a-dihydro-17a-methyltestosterone, 17a-methyl- 19-nortestosterone, 17a-ethyl-3 -deketo- 19-nortestosterone, 17a-methyl-2'H-5a-androst-2-eno[3,2-c]pyrazol-17P-ol, 3,3-[(lE,2E)-l,2-hydrazinediylidene]di(2a,17a-dimethyl-5a- androstan- 17p-ol), 17 -methyl- 19-nor-89-testosterone, 4-hydroxy- 17a-m ethyl- 19- nortestosterone, 17a-methyl-19-nor-59,l 1 -testosterone, 7a, 17a-dimethyl-l 9-nortestosterone, 17a-ethenyltestosterone, 17a-ethyl - 18-m ethyl - 19-nortestosterone, 17 a-ethyl- 19- nortestosterone, 17a,18-dimethyl-19-nor-89,l 1 -testosterone, 17a-ethyl-l 8-m ethyl- 19-nor- 89,11 -testosterone, 3-deketo-17a-ethyl-19-nor-5-androstenediol, 17a-ethyl-l 9-nortestosterone 3-propionate, 17a-ethenyl-l 9-nortestosterone, 17a-ethynyltestosterone, 2,3-isoxazol-17a- ethynyltestosterone, 17 a-ethy nyl- 19-nortestosterone, 17 a-ethynyl-3 -deketo-3 P-hy droxy- 19- nortestosterone, 17a-ethynyl-18-methyl-19-nor-69, 11 -testosterone, (-)-17a-ethynyl-18-methyl- 19-nortestosterone, 17 a-ethynyl-3 -deketo- 19-nortestosterone, 17a-ethynyl- 18-m ethyl- 19- nortestosterone, 17a-ethynyl-19-nor-89,l 1 -testosterone, 7a-methyl-17a-ethynyl-19-nor-85(10)- testosterone, 4-hydro-19-nor-83, 5 -testosterone 3-cyclopentyl ether, 17a-ethynyl-19- nortestosterone 17P-acetate, 17a-ethynyl -3 -deketo-3 P-hydroxy-19-nortestosterone 3p, 17P- diacetate, 17a-ethynyl-l 9-nortestosterone 17P-enanthate, and 4-hydro-17a-ethynyl-19-nor- 83, 5 -testosterone 3-cyclopentyl ether 17p-acetate. In some embodiments, a composition disclosed herein comprises a testosterone derivative.

[0024] In some embodiments, a composition disclosed herein can comprise Androderm, AndroGel (e.g., as described in U.S. Patent No. 8,466,136, U.S. Patent No. 8,466,137, U.S. Patent No. 8,466,138, U.S. Patent No. 8,486,925, U.S. Patent No. 8,729,057, U.S. Patent No. 8,741,881, U.S. Patent No. 8,754,070, U.S. Patent No. 8,759,329), Aveed (e.g., as described in U.S. Patent No. 7,718,640, U.S. Patent No. 8,338,395), Depo-Testosterone, Fortesta, Jatenzo (e.g., as described in U.S. Patent No. 8,241,664, U.S. Patent No. 8,492,369, U.S. Patent No. 8,778,916, U.S. Patent No. 10,543,219, U.S. Patent No. 10,617,696, U.S. Patent No. 11,179,402, U.S. Pat ent No.11, 179, 403, U.S. Patent No. 11,331,325, U.S. Patent No. 11,426,416, U.S. Patent No. 11,564,933), Kyzatrex (e.g., as described in U.S. Patent No. 10,576,089, U.S. Patent No. 10576,090, U.S. Patent No. 11590,146, U.S. Patent No.11,617,758), Natesto (e.g., as described in U.S. Patent No. 8,574,622, U.S. Patent No. 8,784,869, U.S. Patent No. 8,784,882, U.S. Patent No. 8,877,230, U.S. Patent No. 11,090312), Testim, Testopel, Tlando (e.g., as described in U.S. Patent No. 8,778,922, U.S. Patent No. 8,865,695, U.S. Patent No.9, 943, 527, U.S. Patent No. 9,949,985, U.S. Patent No. 10,226,473, U.S. Patent No. 10,716,794, U.S. Patent No. 11,304,960, U.S. Patent No. 11,311,555, U.S. Patent No. 11,364,249, U.S. Patent No. 11,433,083, U.S. Patent No. 11,464,735, U.S. Patent No. 11,559,530, U.S. Patent No. 12,011,503), Vogelxo (e.g., as described in U.S. Patent No. 8,785,426, U.S. Patent No. 9,295,675, U.S. Patent No.9,662,340), or Xyosted (e.g., as described in U.S. Patent No. 8,021,335, U.S. Patent No.8,562,564, U.S. Patent No. 9,180,259, U.S. Patent No. 9,533,102, U.S. Patent No. 9,629,959,U.S. Patent No. 9,744,302, U.S. Patent No. 9,950,125, U.S. Patent No. 10,238,662, U.S.Patent No. 10,279,131, U.S. Patent No. 10,357,609, U.S. Patent No. 10,478,560, U.S. PatentNo. 10,646,495, U.S. Patent No. 10,821,072, U.S. Patent No. 10,881,798, U.S. Patent No.10,905,827, U.S. Patent No. 10,912,782, U.S. Patent No. 11,160,751, U.S. Patent No.11,191,908, U.S. Patent No. 11,446,440, U.S. Patent No. 11,446,441, U.S. Patent No.11,497,753, U.S. Patent No. 11,813,435, U.S. Patent No. 11,844,804), each of which is herein incorporated by reference in its entirety.

[0025] Several moieties of testosterone or a derivative thereof as described herein can be substituted or unsubstituted to form a testosterone derivative, as would be understood by a person of ordinary skill in the art. Non-limiting examples of optional substituents include hydroxyl groups, sulfhydryl groups, halogens, amino groups, nitro groups, nitroso groups, cyano groups, azido groups, sulfoxide groups, sulfone groups, sulfonamide groups, carboxyl groups, carboxaldehyde groups, imine groups, alkyl groups, halo-alkyl groups, alkenyl groups, halo-alkenyl groups, alkynyl groups, halo- alkynyl groups, alkoxy groups, aryl groups, aryloxy groups, aralkyl groups, arylalkoxy groups, heterocyclyl groups, acyl groups, acyloxy groups, carbamate groups, amide groups, ureido groups, epoxy groups, and ester groups. In some embodiments, one substitution is made to form a testosterone derivative. In some embodiments, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more substitutions are made to form a testosterone derivative.

[0026] Non-limiting examples of alkyl groups include straight, branched, and cyclic alkyl groups. An alkyl group can be, for example, a Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cl 1, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C23, C24, C25, C26, C27, C28, C29, C30, C31, C32, C33, C34, C35, C36, C37, C38, C39, C40, C41, C42, C43, C44, C45, C46, C47, C48, C49, or C50 group that is substituted or unsubstituted.

[0027] Non-limiting examples of straight alkyl groups include methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, octyl, nonyl, and decyl.

[0028] Branched alkyl groups include any straight alkyl groups substituted with any number of alkyl groups. Non-limiting examples of branched alkyl groups include isopropyl, isobutyl, sec-butyl, and t-butyl.

[0029] Non-limiting examples of substituted alkyl groups include hydroxymethyl, chloromethyl, trifluoromethyl, aminomethyl, 1 -chloroethyl, 2-hydroxy ethyl, 1,2- difluoroethyl, and 3-carboxypropyl.

[0030] Non-limiting examples of cyclic alkyl groups include cyclopropyl, cyclobutyl, cyclopentyl, cyclohexyl, cycloheptyl, and cyclooctyl groups. Cyclic alkyl groups also include fused-, bridged-, and spiro-bicycles and higher fused-, bridged-, and spiro-systems. A cyclic alkyl group can be substituted with any number of straight, branched, or cyclic alkyl groups. Non-limiting examples of cyclic alkyl groups include cyclopropyl, 2-methyl- cycloprop-l-yl, cycloprop-2-en-l-yl, cyclobutyl, 2,3-dihydroxycyclobut-l-yl, cyclobut-2-en- 1-yl, cyclopentyl, cyclopent-2-en-l-yl, cyclopenta-2,4-dien-l-yl, cyclohexyl, cyclohex-2-en-1-yl, cycloheptyl, cyclooctanyl, 2,5-dimethylcyclopent-l-yl, 3,5-dichlorocyclohex-l-yl, 4- hydroxycyclohex-l-yl, 3,3,5-trimethylcyclohex-l-yl, octahydropentalenyl, octahydro- \H- indenyl, 3a,4,5,6,7,7a-hexahydro-31 / -inden-4-yl, decahydroazulenyl, bicyclo- [2.1.1]hexanyl, bicyclo[2.2.1]heptanyl, bicyclo[3.1.1]heptanyl, l,3-dimethyl[2.2.1]heptan-2-yl, bicyclo[2.2.2]octanyl, and bicyclo[3.3.3]undecanyl.

[0031] Non-limiting examples of alkenyl and alkenylene groups include straight, branched, and cyclic alkenyl groups. The olefin or olefins of an alkenyl group can be, for example, E, Z, cis, trans, terminal, or cxo-methylene. An alkenyl or alkenylene group can be, for example, a C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cl l, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C23, C24, C25, C26, C27, C28, C29, C30, C31, C32, C33, C34, C35, C36, C37, C38, C39, C40, C41, C42, C43, C44, C45, C46, C47, C48, C49, or C50 group that is substituted or unsubstituted. Non-limiting examples of alkenyl and alkenylene groups include ethenyl, prop-l-en-l-yl, isopropenyl, but-l-en-4-yl; 2-chloroethenyl, 4-hydroxybuten-l-yl, 7- hydroxy-7-methyloct-4-en-2-yl, and 7-hydroxy-7-methyloct-3, 5-dien-2-yl.

[0032] Non-limiting examples of alkynyl or alkynylene groups include straight, branched, and cyclic alkynyl groups. The triple bond of an alkylnyl or alkynylene group can be internal or terminal. An alkylnyl or alkynylene group can be, for example, a C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cl l, C12, C13, C14, C15, C16, C17, C18, C19, C20, C21, C22, C23, C24, C25, C26, C27, C28, C29, C30, C31, C32, C33, C34, C35, C36, C37, C38, C39, C40, C41, C42, C43, C44, C45, C46, C47, C48, C49, or C50 group that is substituted or unsubstituted. Nonlimiting examples of alkynyl or alkynylene groups include ethynyl, prop-2-yn-l-yl, prop-1- yn-l-yl, and 2-methyl-hex-4-yn-l-yl; 5-hydroxy-5-methylhex-3-yn-l-yl, 6-hydroxy-6- methylhept-3-yn-2-yl, and 5-hydroxy-5-ethylhept-3-yn-l-yl.

[0033] A halo-alkyl group can be any alkyl group substituted with any number of halogen atoms, for example, fluorine, chlorine, bromine, and iodine atoms. A halo-alkenyl group can be any alkenyl group substituted with any number of halogen atoms. A halo-alkynyl group can be any alkynyl group substituted with any number of halogen atoms.

[0034] An alkoxy group can be, for example, an oxygen atom substituted with any alkyl, alkenyl, or alkynyl group. An ether or an ether group comprises an alkoxy group. Nonlimiting examples of alkoxy groups include methoxy, ethoxy, propoxy, isopropoxy, and isobutoxy.

[0035] An aryl group can be heterocyclic or non-heterocyclic. An aryl group can be monocyclic or polycyclic. An aryl group can be substituted with any number of substituents described herein, for example, hydrocarbyl groups, alkyl groups, alkoxy groups, and halogen atoms. Non-limiting examples of aryl groups include phenyl, toluyl, naphthyl, pyrrolyl, pyridyl, imidazolyl, thiophenyl, and furyl. Non-limiting examples of substituted aryl groups include 3,4-dimethylphenyl, 4-terAbutylphenyl, 4- cyclopropylphenyl, 4-diethylaminophenyl, 4-(trifluoromethyl)phenyl, 4- (difluoromethoxy)-phenyl, 4-(trifluoromethoxy)phenyl, 3 -chlorophenyl, 4- chlorophenyl, 3,4-dichlorophenyl, 2-fluorophenyl, 2-chlorophenyl, 2-iodophenyl, 3- iodophenyl, 4-iodophenyl, 2-methylphenyl, 3 -fluorophenyl, 3 -methylphenyl, 3- methoxyphenyl, 4-fluorophenyl, 4-methylphenyl, 4-methoxyphenyl, 2,3- difluorophenyl, 3,4-difluorophenyl, 3,5-difluorophenyl, 2,3-dichlorophenyl, 3,4- dichlorophenyl, 3,5-dichlorophenyl, 2-hydroxyphenyl, 3-hydroxyphenyl, 4- hydroxyphenyl, 2-methoxyphenyl, 3-methoxyphenyl, 4-methoxyphenyl, 2,3- dimethoxyphenyl, 3,4-dimethoxyphenyl, 3,5-dimethoxyphenyl, 2, 4-di fluorophenyl, 2,5- difluorophenyl, 2,6-difluorophenyl, 2,3,4-trifluorophenyl, 2,3,5-trifluorophenyl, 2,3,6- trifluorophenyl, 2,4,5-trifluorophenyl, 2,4,6-trifluorophenyl, 2,4-dichlorophenyl, 2,5- di chlorophenyl, 2,6-dichlorophenyl, 3,4-dichlorophenyl, 2, 3, 4-tri chlorophenyl, 2,3,5- trichlorophenyl, 2,3,6-trichlorophenyl, 2,4,5-trichlorophenyl, 3,4,5-trichlorophenyl,2.4.6-trichlorophenyl, 2,3-dimethylphenyl, 2,4-dimethylphenyl, 2,5-dimethylphenyl,2.6-dimethylphenyl, 2,3,4-trimethylphenyl, 2,3,5-trimethylphenyl, 2,3,6- trimethylphenyl, 2,4,5-trimethylphenyl, 2,4,6-trimethylphenyl, 2-ethylphenyl, 3- ethylphenyl, 4-ethylphenyl, 2,3-diethylphenyl, 2,4-diethylphenyl, 2,5-diethylphenyl,2.6-diethylphenyl, 3,4-diethylphenyl, 2, 3, 4-tri ethylphenyl, 2,3,5-triethylphenyl, 2,3,6- triethylphenyl, 2, 4, 5-tri ethylphenyl, 2, 4, 6-tri ethylphenyl, 2-isopropylphenyl, 3- isopropylphenyl, and 4-isopropylphenyl.

[0036] Non-limiting examples of substituted aryl groups include 2-aminophenyl, 2- (A-methylamino)phenyl, 2-(A,A-dimethylamino)phenyl, 2-(A-ethylamino)phenyl, 2- (A,A-diethylamino)phenyl, 3-aminophenyl, 3-(A-methylamino)phenyl, 3- N,N- dimethylamino)phenyl, 3-( V-ethylamino)phenyl, 3-(A,A-diethylamino)phenyl, 4-aminophenyl, 4-(7V-methylamino)phenyl, 4-(7V, V-dimethylamino)phenyl, 4-( V- ethylamino)phenyl, and 4-(.A,Af-di ethyl ami no)phcnyl.

[0037] A heterocycle can be any ring containing a ring atom that is not carbon, for example, N, O, S, P, Si, B, or any other heteroatom, as would be known to one skilled in the art. A heterocycle can be substituted with any number of substituents, for example, alkyl groups and halogen atoms. A heterocycle can be aromatic (heteroaryl) or non-aromatic. Nonlimiting examples of heterocycles include pyrrole, pyrrolidine, pyridine, piperidine, succinamide, maleimide, morpholine, imidazole, thiophene, furan, tetrahydrofuran, pyran, and tetrahydropyran.

[0038] Non-limiting examples of heterocycles (heterocyclyl) include: heterocyclic units having a single ring containing one or more heteroatoms, non-limiting examples of which include, diazirinyl, aziridinyl, azetidinyl, pyrazolidinyl, imidazolidinyl, oxazolidinyl, isoxazolinyl, thiazolidinyl, isothiazolinyl, oxathiazolidinonyl, oxazolidinonyl, hydantoinyl, tetrahydrofuranyl, pyrrolidinyl, morpholinyl, piperazinyl, piperidinyl, dihydropyranyl, tetrahydropyranyl, piperidin-2-onyl, 2,3,4,5-tetrahydro-l 7-azepinyl, 2,3-dihydro-U / -indole, and 1,2,3,4-tetrahydroquinoline; and ii) heterocyclic units having 2 or more rings one of which is a heterocyclic ring, non-limiting examples of which include hexahydro- \H- pyrrolizinyl, 3a,4,5,6,7,7a-hexahydro-l / / -benzo[dlimidazolyl, 3a,4,5,6,7,7a-hexahydro-l / / - indolyl, 1,2,3,4-tetrahydroquinolinyl, and decahydro-l / 7-cycloocta[blpyrrolyl.

[0039] Non-limiting examples of heteroaryl include: i) heteroaryl rings containing a single ring, non-limiting examples of which include, 1,2,3,4-tetrazolyl, [l,2,31triazolyl, [l,2,41triazolyl, triazinyl, thiazolyl, 1 / / -imidazolyl, oxazolyl, isoxazolyl, isothiazolyl, furanyl, thiophenyl, pyrimidinyl, 2-phenylpyrimidinyl, pyridinyl, 3-methylpyridinyl, and 4-dimethylaminopyridinyl; and ii) heteroaryl rings containing 2 or more fused rings one of which is a heteroaryl ring, nonlimiting examples of which include: 7 / / -purinyl, 9 / / -purinyl, 6-amino-9 / / -purinyl, 5H- pyrrolo[3,2-t / lpyrimidinyl, 7 / / -pyrrolo[2, 3-dl pyrimidinyl, pyrido[2,3-t / lpyrimidinyl, 4, 5,6,7- tetrahydro-l-7 / -indolyl, quinoxalinyl, quinazolinyl, quinolinyl, 8-hydroxy-quinolinyl, and isoquinolinyl.

[0040] Described herein are compositions of progesterone or a pharmaceutically acceptable salt thereof. Progesterone is a steroid hormone involved in pregnancy and embryogenesis. Progesterone is also an intermediate for other endogenous steroid hormones, including testosterone. In some embodiments, progesterone is naturally occurring. Alternatively, in some embodiments, progesterone is synthetic (e.g., progestin). Progesterone has a molecular formula of C21H30O2 and a structure of:Progesterone

[0041] Described herein are compositions of progesterone derivatives or a pharmaceutically acceptable salt thereof. In some embodiments, a progesterone derivative as described herein can be biologically active. In some embodiments, a progesterone derivative as described herein can be a prodrug, which needs to be metabolized to become an active compound. In some embodiments, progesterone derivatives are naturally occurring. Alternatively, in some embodiments, progesterone derivatives are synthetic. Non-limiting examples of progesterone derivatives can include progesterone 3-cyclopenyl enol ether, retroprogesterone, dydrogesterone, trengestone, medrogestone, 17 a- hydroxy progesterone derivatives (e.g., chlormadinone acetate, cyproterone acetate, medroxyprogesterone acetate, megestrol acetate, 313,17a-diacetoxy-6-m ethyl -6-dehy dro-3 -deketoprogesterone, 16a, 17a- dihydroxyprogesterone, 17a-acetoxy-6a-methyl-3 -deketoprogesterone, 17a-acetoxy-6-chloro- 6-dehydroprogesterone, 17a-acetoxy-6-chloro-16-methylene-6-dehydroprogesterone, 17a- acetoxyprogesterone, 17a-acetoxy-l,2a-methylene-6-chloro-6-dehydroprogesterone, 17a- heptanoxyprogesterone, 17a-acetoxy-6-chl oro-1 ,6-didehydro-progesterone, 17a-acetoxy-6a- methylprogesterone, 17a-acetoxy-9a-fluoro-l 113 -hydroxyprogesterone, 17a- Acetoxyprogesterone 3 -cyclopentyl enol ether, 17a-acetoxy-16-methylene-6- dehydroprogesterone, 17a-acetoxy-6a-(trifluoromethyl)progesterone, 17a-acetoxy-6-methyl- 6-dehydroprogesterone, 17a-acetoxy-16-methylene-6-methyl-6-dehydroprogesterone, 17a- acetoxy-6-chloro-2-oxa-6-dehydroprogesterone,), 17a-m ethylprogesterone, 6,17a-dimethyl-6- dehydroprogesterone, 6a-fluoro-17a-bromoprogesterone, 14a, 17 a- propylidenedi oxyprogesterone, 19-norprogesterone derivatives (e.g., nomegestrol, promegestone, trimegestone, 19-norprogesterone, 17a-methyl-9-dehydro-l 9-norprogesterone, 17a-caproxy-l 9-norprogesterone, 17a-acetoxy-6-methyl-6-dehydro-l 9-norprogesterone, 17a- acetoxy-1113-methyl-l 9-norprogesterone, 17a,21-dimethyl-9-dehydro-19-norprogesterone, 17a-acetoxy-16-methylene-19-norprogesterone (segesterone acetate)), testosterone, 19- nortestosterone derivatives (e.g., 19-nortestosterone, 1613-ethyl-19-nortestosterone), norethisterone, lynestrenol, levonorgestrel, desogestrel, gestodene, medroxyprogesterone acetate, 11 -methylene- 17a-ethynyl-l 8-m ethyl- 19-nortestosterone, dienogest, 17a-ethynyl-18-methyl- 19-nor-39, 11-testosterone, 17 a-ethynyl- 18-methyl- 19-nortestosterone 3 -oxime, norgestimate, rac-13-ethyl-17a-ethynyl-19-nortestosterone, hydroxyprogesterone caproate, algestone acetophenide, hydroxyprogesterone, 17a-ethynyltestosterone, 2,3-isoxazol-17a- ethynyltestosterone, 6a, 21 -dimethyl- 17a-ethynyltestosteron, 17a-ethynyl-3-deketo-313- hydroxy-19-nortestosterone 313,1713-diacetate, 17a-ethynyl-l 9-nortestosterone 1713- acetate, 17a-ethynyl-19-nortestosterone 1713-enanthate, 17a-ethynyl-85(10)-19- nortestosterone, 17a-ethynyl- 19-nor-89 1'-testosterone, 4-hydro-l 7a-ethynyl- 19-nor-83’5- testosterone 3-cyclopentyl ether 1713-acetate, 7a-methyl-17a-ethynyl-19-nor-85(10)- testosterone, 3 -deketo- 17a-allyl-l 9-nortestosterone, 17a-allyl-19-nor-89’"-testosterone, 17a- cy anomethyl- 19-nor-89-testosterone, 17 a-methyl- 19-nortestosterone, 17 a- vinyl- 19- nortestosterone, 17a-vinyl-85(10)-l 9-nortestosterone and spironolactone derivatives (e.g., drospirenone, 17a-(2-carboxyethyl)testosterone y-lactone). In some embodiments, a composition disclosure herein comprises a progesterone derivative.

[0042] Several moieties of progesterone or a derivative thereof as described herein can be substituted or unsubstituted to form a progesterone derivative, as would be understood by a person of ordinary skill in the art. Non-limiting examples of optional substituents include hydroxyl groups, sulfhydryl groups, halogens, amino groups, nitro groups, nitroso groups, cyano groups, azido groups, sulfoxide groups, sulfone groups, sulfonamide groups, carboxyl groups, carboxaldehyde groups, imine groups, alkyl groups, halo-alkyl groups, alkenyl groups, halo-alkenyl groups, alkynyl groups, halo- alkynyl groups, alkoxy groups, aryl groups, aryloxy groups, aralkyl groups, arylalkoxy groups, heterocyclyl groups, acyl groups, acyloxy groups, carbamate groups, amide groups, ureido groups, epoxy groups, and ester groups. In some embodiments, one substitution is made to form a progesterone derivative. In some embodiments, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more substitutions are made to form a progesterone derivative.

[0043] Segesterone acetate, also known as 16-methylene-17a-acetoxy-19-norpregn-4-ene-3, 20- dione or nestorone, is a progesterone derivative. Described herein are compositions of segesterone acetate or a pharmaceutically acceptable salt thereof. In some embodiments, a composition disclosed herein comprises segesterone acetate. Segesterone acetate is an agonist of the progesterone receptor. Segesterone acetate has anti gonadotropic effects and functional antiestrogenic effects. In some embodiments, segesterone acetate is naturally occurring. Alternatively, in some embodiments, segesterone acetate is synthetic. Segesterone acetate has a molecular formula of C23H30O4 and a structure ofSegesterone Acetate

[0044] Described herein are compositions of segesterone acetate derivatives or a pharmaceutically acceptable salt thereof. In some embodiments, segesterone acetate derivatives are naturally occurring. Alternatively, in some embodiments, segesterone acetate derivatives are synthetic. In some embodiments, a segesterone acetate derivative as described herein can be biologically active. In some embodiments, a segesterone acetate derivative as described herein can be a prodrug, which needs to be metabolized to become an active compound. Non-limiting examples of segesterone acetate derivatives can include 18-methylsegesterone acetate.

[0045] Several moieties of segesterone acetate or a derivative thereof as described herein can be substituted or unsubstituted to form a segesterone acetate derivative, as would be understood by a person of ordinary skill in the art. Non-limiting examples of optional substituents include hydroxyl groups, sulfhydryl groups, halogens, amino groups, nitro groups, nitroso groups, cyano groups, azido groups, sulfoxide groups, sulfone groups, sulfonamide groups, carboxyl groups, carboxaldehyde groups, imine groups, alkyl groups, halo-alkyl groups, alkenyl groups, halo-alkenyl groups, alkynyl groups, halo- alkynyl groups, alkoxy groups, aryl groups, aryloxy groups, aralkyl groups, arylalkoxy groups, heterocyclyl groups, acyl groups, acyloxy groups, carbamate groups, amide groups, ureido groups, epoxy groups, and ester groups. In some embodiments, one substitution is made to form a segesterone acetate derivative. In some embodiments, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more substitutions are made to form a segesterone acetate derivative.

[0046] In some embodiments, the compounds disclosed herein can contain one or more asymmetric centers and thus give rise to enantiomers, diastereomers, and other stereoisomeric forms that are defined, in terms of absolute stereochemistry, as (R)- or (S)-. Unless stated otherwise, it is intended that all stereoisomeric forms of the compounds disclosed herein are contemplated by this disclosure. When the compounds described herein contain alkene double bonds, and unless specified otherwise, it is intended that this disclosure includes both E and Z geometric isomers (e.g., cis or trans.) Likewise, all possible isomers, as well as their racemic and optically pure forms, and all tautomeric forms are also intended to be included. Theterm “geometric isomer” refers to E or Z geometric isomers (e.g., cis or trans) of an alkene double bond. The term “positional isomer” refers to structural isomers around a central ring, such as ortho-, meta-, and para-isomers around a benzene ring. The compounds described herein may be asymmetric (e.g., having one or more stereocenters). All stereoisomers, such as enantiomers and diastereomers, are intended unless otherwise indicated. It is understood that, in any compound described herein having one or more chiral centers, if an absolute stereochemistry is not expressly indicated, then each center may independently be the (Reconfiguration, or the (S)-configuration, or a mixture thereof. Thus, the compounds provided herein may be enantiomerically pure, enantiomerically enriched, a racemic mixture, diastereomerically pure, diastereomerically enriched, or a stereoisomeric mixture. Preparation of enantiomerically pure or enantiomerically enriched forms may be accomplished by resolution of racemic mixtures or by using enantiomerically pure or enriched starting materials or by stereoselective or stereospecific synthesis. Stereochemical definitions are available in E. L. Eliel, S. H. Wilen & L. N. Mander, Stereochemistry of Organic Compounds, John Wiley & Sons, Inc., New York, NY, 1994 which is incorporated herein by reference in its entirety. In some embodiments, where the compound described herein is chiral or otherwise includes one or more stereocenters, the compound may be prepared with an enantiomeric excess or diastereomeric excess of greater than about 75%, greater than about 80%, greater than about 85%, greater than about 90%, greater than about 95%, or greater than about 99%. For example, the present disclosure is intended to include Ent-17a-hydroxyandrost-4-en-3-one, which may be referred to as “Ent-Testosterone,” and other enantiomers of testosterone.

[0047] A compound as disclosed herein can be PEGylated. PEGylation comprises covalently linking several hydrophilic chains of polyethylene glycol (PEG) to a compound in order to increase its effective molecular mass. Without wishing to be bound by theory, important clinical advantages are gained by PEGylation. For example, life-time in vivo can be prolonged, owing to the steric interference that protects conjugates from proteolysis in vivo, and the increase in molecular mass can preclude filtration by the kidney. PEGylation can also decrease immunogenicity, presumably by protecting compounds from being recognized as foreign antigens by the immune system.

[0048] At any position of the compound that a hydrogen atom may be present, the hydrogen atom may be an isotopic distribution of hydrogen, including but not limited to protium ^H) and deuterium (2H) in proportional amounts to those usually found in nature and in proportional amounts different to those usually found in nature. Thus, reference herein to a compoundencompasses all potential isotopic distributions for each atom unless the context clearly dictates otherwise. Examples of isotopes include isotopes of hydrogen, carbon, nitrogen, oxygen, phosphorous, sulfur, fluorine, chlorine, bromine, and iodine. As one of skill in the art would appreciate, any of the compounds as disclosed and described herein may include radioactive isotopes. Accordingly, also contemplated is use of compounds as disclosed and described herein, wherein one or more atoms have an isotopic distribution different to those usually found in nature, such as having2H or3H in greater proportion, ornC,13C, or14C in greater proportion than found in nature. By way of general example, and without limitation, isotopes of hydrogen include protium (1H), deuterium (2H), and tritium (3H). Isotopes of carbon include carbon-11 (nC), carbon-12 (12C), carbon-13 (13C), and carbon- 14 (14C). Isotopes of nitrogen include nitrogen- 13 (13N), nitrogen- 14 (14N) and nitrogen- 15 (15N). Isotopes of oxygen include oxygen- 14 (14O), oxygen-15 (15O), oxygen-16 (16O), oxygen- 17 (17O), and oxygen- 18 (18O). Isotope of fluorine include fluorine- 17 (17F), fluorine-18 (18F) and fluorine-19 (19F). Isotopes of phosphorous include phosphorus-31 (31P), phosphorus-32 (32P), phosphorus-33 (33P), phosphorus-34 (34P), phosphorus-35 (35P) and phosphorus-36 (36P). Isotopes of sulfur include sulfur-32 (32S), sulfur-33 (33S), sulfur-34 (34S), sulfur-35 (35S), sulfur-36 (36S) and sulfur-38 (38S). Isotopes of chlorine include chlorine-35 (35C1), chlorine-36 (36C1) and chlorine-37 (37C1 ). Isotopes of bromine include bromine-75 (73Br), bromine-76 (76Br), bromine-77 (77Br), bromine-79 (79Br), bromine-81 (81Br) and bromine-82 (82Br). Isotopes of iodine include iodine-123 (123I), iodine-124 (124I), iodine-125 (125I), iodine-131 (131I) and iodine-135 (135I).

[0049] In some embodiments, atoms at every position of the compound have an isotopic distribution for each chemical element in proportional amounts to those usually found in nature. In some embodiments, an atom in one position of the compound has an isotopic distribution for a chemical element in proportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature). In some embodiments, atoms in at least two positions of the compound independently have an isotopic distribution for a chemical element in proportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature). In some embodiments, atoms in at least three positions of the compound independently have an isotopic distribution for a chemical element in proportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature). In some embodiments, atoms in at least four positions of the compound independently have an isotopic distribution for a chemical element inproportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature). In some embodiments, atoms in at least five positions of the compound independently have an isotopic distribution for a chemical element in proportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature). In some embodiments, atoms in at least six positions of the compound independently have an isotopic distribution for a chemical element in proportional amounts different to those usually found in nature (remainder atoms having an isotopic distribution for a chemical element in proportional amounts to those usually found in nature).

[0050] A compound as disclosed herein can be purified. A compound as disclosed herein can be at least about 1%, at least about 2%, at least about 3%, at least about 4%, at least about 5%, at least about 6%, at least about 7%, at least about 8%, at least about 9%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 55%, at least about 60%, at least about 65%, at least about 70%, at least about 75%, at least about 80%, at least about 85%, at least about 90%, at least about 91%, at least about 92%, at least about 93%, at least about 94%, at least about 95%, at least about 96%, at least about 97%, at least about 98%, at least about 99%, at least about 99.1%, at least about 99.2%, at least about 99.3%, at least about 99.4%, at least about 99.5%, at least about 99.6%, at least about 99.7%, at least about 99.8%, at least about 99.9% or more pure. A compound as disclosed herein can be at most about 100%, at most about 99.9%, at most about 99.8%, at most about 99.7%, at most about 99.6%, at most about 99.5%, at most about 99.4%, at most about 99.3%, at most about 99.2%, at most about 99.1%, at most about 99%, at most about 98%, at most about 97%, at most about 96%, at most about 95%, at most about 94%, at most about 93%, at most about 92%, at most about 91%, at most about 90%, at most about 85%, at most about 80%, at most about 75%, at most about 70%, at most about 65%, at most about 60%, at most about 55%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 9%, at most about 8%, at most about 7%, at most about 6%, at most about 5%, at most about 4%, at most about 3%, at most about 2%, at most about 1%, or less pure.

[0051] Pharmaceutically Acceptable Salts

[0052] The method disclosed herein provides the use of pharmaceutically acceptable salts of any compound described herein. Pharmaceutically acceptable salts include, for example, acid-addition salts and base-addition salts. The acid that is added to the compound to form an acidaddition salt can be an organic acid or an inorganic acid. A base that is added to the compound to form a base-addition salt can be an organic base or an inorganic base.

[0053] Pharmaceutically acceptable acid addition salts may be formed by combining a compound having a basic moiety with inorganic acids and organic acids. Inorganic acids which may be used to prepare salts include, for example, hydrochloric acid, hydrobromic acid, sulfuric acid, nitric acid, phosphoric acid, and the like. Organic acids which may be used to prepare salts include, for example, methanesulfonic acid, ethanesulfonic acid, p-toluenesulfonic acid, and the like. Pharmaceutically acceptable base addition salts may be formed by combining a compound having an acidic moiety with inorganic and organic bases. Inorganic bases which may be used to prepare salts include, for example, sodium, potassium, lithium, ammonium, calcium, magnesium, iron, zinc, manganese, aluminum hydroxides, carbonates, bicarbonates, phosphates, and the like. In some embodiments, the inorganic base salt is ammonium, potassium, sodium, calcium, and magnesium hydroxides, carbonates, bicarbonates, or phosphates. Organic bases from which may be used to prepare salts include, for example, primary, secondary, and tertiary amines, substituted amines including naturally occurring substituted amines, cyclic amines, basic ion exchange resins, and the like, specifically such as isopropylamine, trimethylamine, diethylamine, triethylamine, tripropylamine, and ethanolamine. Generally, such salts may be prepared by reacting the free acid or base forms of these compounds with at least a stoichiometric amount of the appropriate base or acid in water or in an organic solvent, or in a mixture of the two; generally, non-aqueous media like ether, ethyl acetate, alcohols (e.g., methanol, ethanol, iso-propanol, or butanol) or acetonitrile (ACN). Lists of suitable salts are found in WO 87 / 05297; Johnston et al., published Sep. 11, 1987; Remington's Pharmaceutical Sciences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418; and J. Pharm. Set., 66, 2 (1977); each of which is incorporated herein by reference in its entirety. A reference for the preparation and selection of pharmaceutical salts of the present disclosure is P. H. Stahl & C. G. Wermuth, Handbook of Pharmaceutical Salts, Verlag Helvetica Chimica Acta, Zurich, 2002 which is incorporated herein by reference in its entirety. Other excipients known to those of skill in the art are also contemplated as being useful when formulated in the compositions described herein.

[0054] Acid addition salts can arise from the addition of an acid to a compound disclosed herein. In some embodiments, the acid is organic. In some embodiments, the acid is inorganic. In some embodiments, the acid is lactic acid, salicylic acid, tartaric acid, ascorbic acid, gentisinic acid, gluconic acid, glucaronic acid, saccaric acid, formic acid, benzoic acid, glutamic acid,pantothenic acid, acetic acid, propionic acid, butyric acid, fumaric acid, succinic acid, methanesulfonic acid, ethanesulfonic acid, benzenesulfonic acid, p-toluenesulfonic acid, citric acid, oxalic acid, maleic acid, hydrochloric acid, hydrobromic acid, hydroiodic acid, nitric acid, nitrous acid, sulfuric acid, sulfurous acid, a phosphoric acid, or isonicotinic acid. In some embodiments, the salt is an acid addition salt with lactic acid.

[0055] In some embodiments, the salt is a lactate salt, a salicylate salt, a tartrate salt, an ascorbate salt, a gentisinate salt, a gluconate salt, a glucaronate salt, a saccarate salt, a formate salt, a benzoate salt, a glutamate salt, a pantothenate salt, an acetate salt, a propionate salt, a butyrate salt, a fumarate salt, a succinate salt, a methanesulfonate salt, an ethanesulfonate salt, a benzenesulfonate salt, a p-toluenesulfonate salt, a citrate salt, an oxalate salt, a maleate salt, hydrochloride salt, a hydrobromide salt, a hydroiodide salt, a nitrate salt, a nitrite salt, a sulfate salt, a sulfite salt, a phosphate salt, isonicotinate salt. In some embodiments, the salt is a lactate salt. In some embodiments, the salt is a monolactate salt.

[0056] Metal salts can arise from the addition of an inorganic base to a compound disclosed herein. The inorganic base consists of a metal cation paired with a basic counterion, such as, for example, hydroxide, carbonate, bicarbonate, or phosphate. The metal can be an alkali metal, alkaline earth metal, transition metal, or main group metal. In some embodiments, the metal is lithium, sodium, potassium, cesium, cerium, magnesium, manganese, iron, calcium, strontium, cobalt, titanium, aluminum, copper, cadmium, or zinc.

[0057] In some embodiments, a metal salt is a lithium salt, a sodium salt, a potassium salt, a cesium salt, a cerium salt, a magnesium salt, a manganese salt, an iron salt, a calcium salt, a strontium salt, a cobalt salt, a titanium salt, an aluminum salt, a copper salt, a cadmium salt, or a zinc salt.

[0058] It will be apparent to those skilled in the art that the dosage forms described herein may comprise, as the drug substance, either a compound described herein (e.g., testosterone and / or segesterone acetate) or pharmaceutically acceptable salt, solvate, or hydrate thereof. Moreover, various hydrates and solvates of the compounds described herein and their salts may find use as intermediates in the manufacture of pharmaceutical compositions. Typical procedures for making and identifying suitable hydrates and solvates, outside those mentioned herein, are well known to those in the art; see for example, pages 202-209 of K. J. Guillory, “Generation of Polymorphs, Hydrates, Solvates, and Amorphous Solids,” in: Polymorphism in Pharmaceutical Solids, ed. Harry G. Britain, Vol. 95, Marcel Dekker, Inc., New York, 1999 which is incorporated herein by reference in its entirety. Accordingly, one aspect of the present invention pertains to methods of administering hydrates and solvates of compounds described hereinand / or their pharmaceutical acceptable salts, that may be isolated and characterized by methods known in the art, such as, thermogravimetric analysis (TGA), TGA-mass spectroscopy, TGA- Infrared spectroscopy, powder X-ray diffraction (PXRD), Karl Fisher titration, high resolution X-ray diffraction, and the like.

[0059] Therapeutic Methods

[0060] Hormones are signaling molecules that regulate physiology and behavior. Classes of hormones include eicosanoids, steroids, amino acid derivatives, peptides, and gasses. Steroid hormones are hormones derived from cholesterol. In humans, steroids are secreted by the adrenal cortex, the testes, the ovaries, and the placenta. Steroid hormones include glucocorticoids, mineralocorticoids, and sex hormones.

[0061] Sex hormones, also known as gonadocorticoids or gonadal steroids, are hormones that can be important factors in reproduction. Sex hormones can be produced in the ovaries in females or in the testes in males. The three main classes of sex hormones are androgens, estrogens, and progestogens.

[0062] Androgens can be considered male sex hormones which regulate the development and maintenance of male characteristics by binding to androgen receptors. Androgens mediate the development of masculine secondary sex characteristics and are important for spermatogenesis and fertility. Non-limiting examples of androgens include testosterone, dihydrotestosterone, dehydroepiandrosterone, dehydroepiandrosterone sulfate, androstenediol, and androstenedione.

[0063] Estrogens can be considered female sex hormones which regulate the development and maintenance of female characteristics by binding to estrogen receptors. Estrogens mediate the development of the female reproductive system and feminine secondary sex characteristics. Non-limiting examples of estrogens include estrogen, estradiol, and estriol.

[0064] Progestogens can be considered sex hormones which affect both the male and female reproductive systems by binding progesterone receptors. In males, progestogens can be involved in spermiogenesis, and testosterone synthesis. Non-limiting examples of progestogens include progesterone, 16a-hydroxyprogesterone, 17a-hydroxyprogesterone, 20a-dihydroprogesterone, 20p-dihydroprogesterone, 5a-dihydroprogesterone, 5p-dihydroprogesterone, 3p- dihydroprogesterone, 11 -deoxycorticosterone, and 5a-dihydrodeoxy corticosterone.

[0065] Hormones can act as contraceptives by mediating male and female reproductive systems. For example, in females, hormonal contraceptives can stop ovulation, thin the uterine lining to prevent implantation, thicken cervical mucous to prevent sperm from reaching the egg. In males, hormonal contraceptives can reduce sperm production.

[0066] Testosterone is a male sex hormone produced in the testes, and which plays an important role in spermatogenesis. Without wishing to be bound by theory, testosterone can function as a contraceptive by suppressing secretion of the two pituitary gonadotropins, luteinizing hormone (LH) and follicle stimulating hormone (FSH). Suppression of LH and FSH can decrease endogenous testosterone secretion in the testes, inhibiting spermatogenesis (see e.g., Anawalt B. D. et al., “Combined nestorone-testosterone gel suppresses serum gonadotropins to concentrations associated with effective hormonal contraception in men”, Andrology, Vol.7, No. 6, pg. 878-887 or Mahabadi Vahid et al., “Combined transdermal testosterone gel and the progestin nestorone suppresses serum gonadotropins in men”, Journal of Clinical Endocrinology and Metabolism, Vol. 94, No. 7, pg. 2313-2320).

[0067] Progesterone is a sex hormone produced in the testes which can be a precursor to testosterone. Without wishing to be bound by theory, progesterone can function as a contraceptive. Progestins, in their function as synthetic progesterone derivatives, can play a similar role in contraception.

[0068] Segesterone acetate is a progesterone derivative that can act as a contraceptive without causing further androgenic, estrogenic, or glucocorticoid actions, even at high doses. Without wishing to be bound by theory, segesterone acetate can increase the rate and extent of spermatogenesis suppression. The rate and extent of spermatogenesis suppression may be adjusted by modifying the dose or proportion of segesterone acetate and / or testosterone, the route of administration, or the combination of excipients.

[0069] A combination of testosterone and progesterone or a derivative thereof (e.g., segesterone acetate) as provided herein can be used as a contraceptive (e.g., a male contraceptive). In some embodiments, the contraceptive can be a male contraceptive. In some embodiments, the contraceptive can be a female contraceptive.

[0070] In some embodiments, a contraceptive composition as described herein (e.g., a combination of testosterone and segesterone acetate), can suppress luteinizing hormone (LH). In some embodiments, a contraceptive composition as described herein (e.g., a combination of testosterone and segesterone acetate), can suppress LH in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 100% as compared to a subject that did not use a contraceptive composition as described herein. In some embodiments, a contraceptive composition as described herein (e.g., testosterone and segesterone acetate), can suppress LH in a subject by at most about 100%, at most about 90%, at most about 80%, at mostabout 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10%, or less.

[0071] In some embodiments, a contraceptive composition as described herein (e.g., testosterone and segesterone acetate), can suppress follicle stimulating hormone (FSH). In some embodiments, a contraceptive composition as described herein (e.g., testosterone and / or segesterone acetate), can suppress FSH in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 100% as compared to a subject that did not use a contraceptive composition as described herein. In some embodiments, a contraceptive composition as described herein (e.g., testosterone and / or segesterone acetate), can suppress FSH in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10%, or less.

[0072] In some embodiments, a contraceptive composition as described herein (e.g. testosterone and / or segesterone acetate), can decrease endogenous testosterone secretion in the testes. In some embodiments, a contraceptive composition as described herein (e.g., testosterone and / or segesterone acetate), can decrease endogenous testosterone secretion in the testes of a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that did not use a contraceptive composition as described herein. In some embodiments, a contraceptive composition as described herein (e.g., testosterone and / or segesterone acetate), can decrease endogenous testosterone secretion in the testes of a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10% or less.

[0073] In some embodiments, a contraceptive composition as described herein (e.g., testosterone and segesterone acetate) does not affect serum testosterone. For example, in some embodiments, serum testosterone can be maintained at a normal physiological range (e.g., 300- 1,000 nanograms per deciliter (ng / dL)). In some embodiments, serum testosterone can be maintained between about 100 ng / dL and about 2,000 ng / dL, about 100 ng / dL and about 1,500 ng / dL, about 100 ng / dL and about 1,000 ng / dL, about 100 ng / dL and about 500 ng / dL, about 200 ng / dL and about 2,000 ng / dL, about 200 ng / dL and about 1,800 ng / dL, about 200 ng / dL and about 1,500 ng / dL, about 200 ng / dL and about 1,000 ng / dL, about 200 ng / dL and about 500 ng / dL, about 300 ng / dL and about 2,000 ng / dL, about 300 ng / dL and about 1,500 ng / dL, about300 ng / dL and about 1,000 ng / dL, about 300 ng / dL and about 500 ng / dL, about 400 ng / dL and about 2,000 ng / dL, about 400 ng / dL and about 1,500 ng / dL, about 400 ng / dL and about 1,050 ng / dL, about 400 ng / dL and about 1,000 ng / dL, or about 400 ng / dL and about 500 ng / dL.

[0074] In some embodiments, serum testosterone can be maintained at least about 50 ng / dL, at least about 100 ng / dL, at least about 150 ng / dL, at least about 200 ng / dL, at least about 250 ng / dL, at least about 300 ng / dL, at least about 350 ng / dL, at least about 400 ng / dL, at least about 450 ng / dL, at least about 500 ng / dL, at least about 600 ng / dL, at least about 700 ng / dL, at least about 800 ng / dL, at least about 900 ng / dL, at least about 1,000 ng / dL, at least about 1,500 ng / dL, or at least about 2,000 ng / dL. In some embodiments, serum testosterone can be maintained at most about 2,000 ng / dL, at most about 1,500 ng / dL, at most about 1,000 ng / dL, at most about 900 ng / dL, at most about 800 ng / dL, at most about 700 ng / dL, at most about 600 ng / dL, at most about 500 ng / dL, at most about 450 ng / dL, at most about 400 ng / dL, at most about 350 ng / dL, at most about 300 ng / dL, at most about 250 ng / dL, at most about 200 ng / dL, at most about 150 ng / dL, at most about 100 ng / dL, or at most about 50 ng / dL.

[0075] In some embodiments, a serum testosterone concentration of testosterone in a subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after the administering and ending about 24 hours after the administering.

[0076] In some embodiments, a contraceptive composition as described herein (e.g., testosterone and / or segesterone acetate) can decrease spermatogenesis.

[0077] In some embodiments, a decrease in spermatogenesis can be determined by a decrease in sperm count. In some embodiments, a contraceptive composition as described herein can lower sperm count in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that did not use a contraceptive composition as described herein. In some embodiments, a contraceptive composition as described herein can lower sperm count in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10% or less as compared to a subject that did not use a contraceptive composition as described herein.

[0078] In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof can lower sperm count in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at leastabout 100% as compared to a subject that used a therapeutic composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof. In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof can lower sperm count in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10%, or less as compared to a subject that used a therapeutic composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof.

[0079] In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof can lower sperm count in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof. In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof can lower sperm count in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10%, or less as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof.

[0080] In some embodiments, a sperm concentration of a subject receiving the composition is lowered. In some embodiments, a sperm concentration of a subject receiving the composition is lowered compared to baseline (e.g., compared to a sperm concentration before the subject received the composition. In some embodiments, a sperm concentration of a subject receiving the composition is lowered compared to placebo. In some embodiments, a sperm concentration of a subject receiving the composition is lowered compared to a corresponding compositioncomprising differing amounts or concentrations of the substituents of the composition (e.g., testosterone or a derivative thereof or progesterone or a derivative thereof). In some embodiments, sperm concentration is lowered to a concentration of 15 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 14 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 13 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 12 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 10 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 9 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 8 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 7 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 6 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 5 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 4 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 3 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 2 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 1 million sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 750,000 sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 500,000 sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 250,000 sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 100,000 sperm per mL of semen or less. In some embodiments, sperm concentration is lowered to a concentration of 50,000 sperm per mL of semen or less.

[0081] In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 15 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 14 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 13 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 12 million sperm permL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 10 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 9 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 8 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 7 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 6 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 5 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 4 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 3 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 2 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 1 million sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 750,000 sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 500,000 sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 250,000 sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 100,000 sperm per mL of semen or less. In some embodiments, a sperm concentration of a subject receiving, or a subject that has received, the composition is about 50,000 sperm per mL of semen or less.

[0082] In some embodiments, a decrease in spermatogenesis can be determined by a decrease seminal fluid concentration. In some embodiments, a contraceptive composition as described herein can decrease seminal fluid concentration in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that did not use a contraceptive composition as described herein. In some embodiments,a contraceptive composition as described herein can decrease seminal fluid concentration in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10% or less as compared to a subject that did not use a contraceptive composition as described herein.

[0083] In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof can decrease seminal fluid concentration in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof. In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof can decrease seminal fluid concentration in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10% or less as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof.

[0084] In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof can decrease seminal fluid concentration in a subject by at least about 10%, at least about 20%, at least about 30%, at least about 40%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof. In some embodiments, a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof and a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof can decrease seminal fluid concentration in a subject by at most about100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 40%, at most about 30%, at most about 20%, at most about 10% or less as compared to a subject that used a contraceptive composition comprising testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof without a segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof.

[0085] In some embodiments, the use of a contraceptive composition as described herein can cause temporary contraceptive effects. In some embodiments, the use of a contraceptive composition as described herein can cause contraceptive effects that last for at least about 1 hour, at least about 2 hours, at least about 3 hours, at least about 4 hours, at least about 5 hours, at least about 6 hours, at least about 7 hours, at least about 8 hours, at least about 9 hours, at least about 10 hours, at least about 11 hours, at least about 12 hours, at least about 13 hours, at least about 14 hours, at least about 15 hours, at least about 16 hours, at least about 17 hours, at least about 18 hours, at least about 19 hours, at least about 20 hours, at least about 21 hours, at least about 22 hours, at least about 23 hours, at least about 24 hours, at least about 25 hours, at least about 26 hours, at least about 27 hours, at least about 28 hours, at least about 29 hours, at least about 30 hours, at least about 31 hours, at least about 32 hours, at least about 33 hours, at least about 34 hours, at least about 35 hours, at least about 36 hours, at least about 37 hours, at least about 38 hours, at least about 39 hours, at least about 40 hours, at least about 41 hours, at least about 42 hours, at least about 43 hours, at least about 44 hours, at least about 45 hours, at least about 46 hours, at least about 47 hours, at least about 48 hours, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 7 days, at least about 8 days, at least about 9 days, at least about 10 days, at least about 11 days, at least about 12 days, at least about 13 days, at least about 14 days, at least about 3 weeks, at least about 4 weeks, at least about 5 weeks, at least about 6 weeks, at least about 7 weeks, at least about 8 weeks, at least about 3 months, at least about 4 months, at least about 5 months, at least about 6 months, or more after use of the contraceptive composition as described herein as ceased.

[0086] In some embodiments, the use of a contraceptive composition as described herein can cause contraceptive effects that last for at most about 6 months, at most about 5 months, at most about 4 months, at most about 3 months, at most about 8 weeks, at most about 7 weeks, at most about 6 weeks, at most about 5 weeks, at most about 4 weeks, at most about 3 weeks, at most about 14 days, at most about 13 days, at most about 12 days, at most about 11 days, at most about 10 days, at most about 9 days, at most about 8 days, at most about 7 days, at most about 6 days, at most about 5 days, at most about 4 days, at most about 3 days, at most about 48 hours, at most about 47 hours, at most about 46 hours, at most about 45 hours, at most about 44 hours, atmost about 43 hours, at most about 42 hours, at most about 41 hours, at most about 40 hours, at most about 39 hours, at most about 38 hours, at most about 37 hours, at most about 36 hours, at most about 35 hours, at most about 34 hours, at most about 33 hours, at most about 32 hours, at most about 31 hours, at most about 30 hours, at most about 29 hours, at most about 28 hours, at most about 27 hours, at most about 26 hours, at most about 25 hours, at most about 24 hours, at most about 23 hours, at most about 22 hours, at most about 21 hours, at most about 20 hours, at most about 19 hours, at most about 18 hours, at most about 17 hours, at most about 16 hours, at most about 15 hours, at most about 14 hours, at most about 13 hours, at most about 12 hours, at most about 11 hours, at most about 10 hours, at most about 9 hours, at most about 8 hours, at most about 7 hours, at most about 6 hours, at most about 5 hours, at most about 4 hours, at most about 3 hours, at most about 2 hours, at most about 1 hour or less after use of the contraceptive composition as described herein as ceased.

[0087] In some embodiments, the use of a contraceptive composition as described herein is reversable after halting administration of the composition to a subject. In some embodiments, the use of a contraceptive composition as described herein is reversable within at least about 1 hour, at least about 2 hours, at least about 3 hours, at least about 4 hours, at least about 5 hours, at least about 6 hours, at least about 7 hours, at least about 8 hours, at least about 9 hours, at least about 10 hours, at least about 11 hours, at least about 12 hours, at least about 13 hours, at least about 14 hours, at least about 15 hours, at least about 16 hours, at least about 17 hours, at least about 18 hours, at least about 19 hours, at least about 20 hours, at least about 21 hours, at least about 22 hours, at least about 23 hours, at least about 24 hours, at least about 25 hours, at least about 26 hours, at least about 27 hours, at least about 28 hours, at least about 29 hours, at least about 30 hours, at least about 31 hours, at least about 32 hours, at least about 33 hours, at least about 34 hours, at least about 35 hours, at least about 36 hours, at least about 37 hours, at least about 38 hours, at least about 39 hours, at least about 40 hours, at least about 41 hours, at least about 42 hours, at least about 43 hours, at least about 44 hours, at least about 45 hours, at least about 46 hours, at least about 47 hours, at least about 48 hours, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 7 days, at least about one week, at least about 8 days, at least about 9 days, at least about 10 days, at least about 11 days, at least about 12 days, at least about 13 days, at least about 14 days, at least about 3 weeks, at least about 4 weeks, at least about 1 month, at least about 5 weeks, at least about 6 weeks, at least about 7 weeks, at least about 8 weeks, at least about 3 months, at least about 4 months, at least about 5 months, at least about 6 months, at least about 1 year, at least about 2 years, or more after halting administration of the composition to the subject.

[0088] In some embodiments, the use of a contraceptive composition as described herein is reversable within at most about 2 years, at most about 1 year, at most about 6 months, at most about 5 months, at most about 4 months, at most about 3 months, at most about 8 weeks, at most about 7 weeks, at most about 6 weeks, at most about 5 weeks, at most about 1 month, at most about 4 weeks, at most about 3 weeks, at most about 14 days, at most about 13 days, at most about 12 days, at most about 11 days, at most about 10 days, at most about 9 days, at most about 8 days, at most about 1 week, at most about 7 days, at most about 6 days, at most about 5 days, at most about 4 days, at most about 3 days, at most about 48 hours, at most about 47 hours, at most about 46 hours, at most about 45 hours, at most about 44 hours, at most about 43 hours, at most about 42 hours, at most about 41 hours, at most about 40 hours, at most about 39 hours, at most about 38 hours, at most about 37 hours, at most about 36 hours, at most about 35 hours, at most about 34 hours, at most about 33 hours, at most about 32 hours, at most about 31 hours, at most about 30 hours, at most about 29 hours, at most about 28 hours, at most about 27 hours, at most about 26 hours, at most about 25 hours, at most about 24 hours, at most about 23 hours, at most about 22 hours, at most about 21 hours, at most about 20 hours, at most about 19 hours, at most about 18 hours, at most about 17 hours, at most about 16 hours, at most about 15 hours, at most about 14 hours, at most about 13 hours, at most about 12 hours, at most about 11 hours, at most about 10 hours, at most about 9 hours, at most about 8 hours, at most about 7 hours, at most about 6 hours, at most about 5 hours, at most about 4 hours, at most about 3 hours, at most about 2 hours, at most about 1 hour or less after halting administration of the composition to the subject.

[0089] In some embodiments, the use of a contraceptive composition as described herein can cause permanent contraceptive effects.

[0090] In some embodiments, the use of a contraceptive composition as described herein can cause fewer side effects than other forms of contraception. Side effects of other forms of contraception (e.g., male contraception) can include but are not limited to acne, night sweats, weight gain, and decreased sex drive.

[0091] In some embodiments, use of the therapeutic composition as described herein can reduce a side effect (e.g., a side effect of a progesterone). The reduction in the side effect can be a reduced severity of the side effect and / or a reduced occurrence of the side effect. Exemplary side effects that may be reduced include low libido (e.g., sex drive), hair loss, weight gain, fatigue, depression, gynecomastia, erectile dysfunction, impotence, bone loss, muscle loss, psychological effects (e.g., mood swings, anxiety, etc.) or any combination thereof.

[0092] In some embodiments, use of the therapeutic composition as described herein can treat or prevent hypogonadism (also known as low testosterone) or a related symptom thereof. Hypogonadism may be diagnosed in any appropriate manner, including but not limited to: measuring total testosterone levels, luteinizing hormone (LH) levels, prolactin levels, or any combination thereof. For example, in some embodiments, hypogonadism can be diagnosed as a blood testosterone level of less than 300 nanograms per deciliter. In some embodiments, hypogonadism can also be diagnosed as a blood testosterone level in combination with abovenormal LH levels. In some embodiments, a composition described herein can treat, improve, or prevent a symptom of low testosterone. Symptoms of low testosterone can include, for example, a reduced sex drive, erectile dysfunction, decreased spontaneous erections, loss of armpit and / or pubic hair, shrinking testicles, hot flashes, depressed mood, difficulties with concentration and memory, increased body fat, gynecomastia, decreased muscle strength and / or mass, and decreased endurance. In some embodiments, treatment with any composition as described herein can increase a blood testosterone level (e.g., above 300 nanograms per deciliter or as otherwise described herein). In some embodiments, treatment with any composition as described herein can treat hypogonadism or a symptom thereof while also acting as a contraceptive.

[0093] In some embodiments, the use of a contraceptive composition as described herein can have reduced incidence of acne as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 100%, or more reduced incidence of acne as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of acne as compared to other forms of contraception (e.g., male contraception).

[0094] In some embodiments, the use of a contraceptive composition as described herein can have reduced incidence of acne as compared to not having the composition. In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%,at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 100%, or more reduced incidence of acne as compared to not having the composition. In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of acne as compared to not having the composition.

[0095] In some embodiments, the use of a contraceptive composition as described herein can have reduced incidence of acne as compared to having a composition comprising a lower dose of testosterone. In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, or at least about 100%, or more reduced incidence of acne as compared to having a composition comprising a lower dose of testosterone. In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of acne as compared to having a composition comprising a lower dose of testosterone.

[0096] In some embodiments, the use of a contraceptive composition as described herein can result in a subject having reduced incidence of night sweats as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% or more reduced incidence of night sweats as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at mostabout 5%, or less reduced incidence of night sweats as compared to other forms of contraception (e.g., male contraception).

[0097] In some embodiments, the use of a contraceptive composition as described herein can have reduced incidence of weight gain as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% reduced incidence of weight gain as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of weight gain as compared to other forms of contraception (e.g., male contraception).

[0098] In some embodiments, the use of a contraceptive composition as described herein can have reduced incidence of decreased sex drive as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% reduced incidence of decreased sex drive as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of decreased sex drive as compared to other forms of contraception (e.g., male contraception).

[0099] In some embodiments, the use of a contraceptive composition as described herein can have decreased incidence of mood swings as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%,at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% reduced incidence of mood swings as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of mood swings as compared to other forms of contraception (e.g., male contraception).

[0100] In some embodiments, the use of a contraceptive composition as described herein can have decreased incidence of anxiety as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% reduced incidence of anxiety as compared to other forms of contraception (e.g., male contraception). In some embodiments, the use of a contraceptive composition as described herein can have an at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less reduced incidence of anxiety as compared to other forms of contraception (e.g., male contraception).

[0101] In some embodiments, the use of a contraceptive composition as described herein can cause health benefits. For example, the use of a contraceptive composition as described herein can have acne-reducing benefits, can treat sexual dysfunction, and / or can increase libido.

[0102] In some embodiments, the use of a therapeutic composition as described herein can lower the incidence of acne in a subject as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can lower the incidence of acne in a subject by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can lower the incidence of acne in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, atmost about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less as compared to a control subject.

[0103] In some embodiments, the use of a therapeutic composition as described herein can decrease the incidence of sexual dysfunction in a subject as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can decrease the incidence of sexual dysfunction in a subject by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can decrease the incidence of sexual dysfunction in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less as compared to a control subject.

[0104] In some embodiments, the use of a therapeutic composition as described herein can increase libido in a subject as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can increase libido in a subject by at least about 5%, at least about 10%, at least about 15%, at least about 20%, at least about 25%, at least about 30%, at least about 35%, at least about 40%, at least about 45%, at least about 50%, at least about 60%, at least about 70%, at least about 80%, at least about 90%, at least about 100% as compared to a control subject. In some embodiments, use of a contraceptive composition as described herein can increase libido in a subject by at most about 100%, at most about 90%, at most about 80%, at most about 70%, at most about 60%, at most about 50%, at most about 45%, at most about 40%, at most about 35%, at most about 30%, at most about 25%, at most about 20%, at most about 15%, at most about 10%, at most about 5%, or less as compared to a control subject.

[0105] In some embodiments, the use of a contraceptive composition as described herein can be used in conjunction with other forms of contraception (e.g., a condom, female birth control). In some embodiments, the use of a contraceptive composition as described herein can be used as a stand-alone method for contraception.

[0106] In some embodiments, a contraceptive composition as described herein can further comprise a third active ingredient. In some embodiments, a therapeutic composition asdescribed herein can further comprise a fourth, fifth, sixth, seventh, eighth, ninth, or tenth additional active ingredient.

[0107] In some embodiments, a third active ingredient is another sex hormone, a derivative thereof, or a pharmaceutically acceptable salt thereof. In some embodiments, a third active ingredient is progesterone. In some embodiments, a third active ingredient is a progestin.

[0108] In some embodiments, a third active ingredient is non-hormonal. For example, in some embodiments, a third active ingredient can be a compound (e.g., a spermicide) that can affect sperm motility and / or viability.

[0109] In some embodiments, the composition helps prevent the transmission of a sexually-transmitted disease (STD) and / or sexually-transmitted infection (STI). Appropriate agents for treating and / or preventing an STD and / or STI are known in the art and can be included in the composition by known methods. In some embodiments, a third active ingredient is a therapeutic agent for the treatment or prevention of a STD and / or STI. Alternatively or in addition to, in some embodiments, a third active ingredient is a therapeutic agent for the prevention of contracting a STD and / or a STI. Alternatively or in addition to, in some embodiments, a third active ingredient is a therapeutic agent for the prevention of transmission of a STD and / or a STI. STDs and / or STIs that can be treated and / or prevented through the use of a composition as described herein can be but are not limited to: gonorrhea, syphilis, chlamydia, trichomoniasis, herpes, genital herpes, hepatitis B, viral hepatitis, zika virus, pelvic inflammatory disease, lymphogranuloma venereum, mycoplasma genitalium, bacterial vaginosis, scabies, human immunodeficiency virus (HIV) / acquired immunodeficiency syndrome (AIDS), human papillomavirus (HPV), pubic lice, molluscum contagiosum virus (MCV), and nongonococcal urethritis (NGU).

[0110] A therapeutic agent for the treatment and / or prevention (e g., pre-exposure prophylaxis [PrEP]) of a STD and / or STI can comprise, for example, an antibiotic agent (e.g., ceftriaxone, penicillin, penicillin G, doxycycline, azithromycin, metronidazole, moxifloxacin, pristinamycin, clindamycin phosphate), an antiviral agent (e.g., acyclovir, valacyclovir, famciclovir, entecavir, tenofovir (e.g., tenofovir disoproxil fumarate), lamivudine, adefovir, antiretroviral therapies, podophyllotoxin), or an insecticide (e.g., permethrin, malathion, pyrethrin, piperonyl butoxide). In some embodiments, a therapeutic agent can be used for the treatment or prevention of HIV / AIDS. For example, a therapeutic agent may comprise abacavir, emtricitabine, zidovudine, doravirine, efavirenz, etravirine, nevirapine, rilpivirine, atazanavir, darunavir, fosamprenavir, ritonavir, tipranavir, enfuvirtide, maraviroc,cabotegravir, dolutegravir, raltegravir, fostemsavir, ibalizumab-uiyk lenacapavir, cobicistat, or any combination thereof.

[0111] Pharmaceutical Compositions

[0112] In some embodiments, a pharmaceutical composition or formulation thereof can comprise any contraceptive composition as described herein. In some embodiments, a pharmaceutical composition or formulation thereof can comprise a testosterone, a testosterone derivative, a progesterone, a progesterone derivative, a segesterone acetate, a segesterone acetate derivative, a pharmaceutical salt thereof, or any combination thereof.

[0113] In some embodiments, a pharmaceutical composition as disclosed herein can comprise testosterone, a testosterone derivative, a pharmaceutically-acceptable salt thereof, or a combination thereof. In some embodiments, a pharmaceutical composition can comprise a therapeutically-effective amount of testosterone or a testosterone derivative.

[0114] In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically acceptable salt thereof as described herein can be administered in a dosage form. In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically- acceptable salt thereof is present in a formulation in an amount of at least about 1 milligram per milliliter (mg / mL), at least about 2 mg / mL, at least about 3 mg / mL, at least about 4 mg / mL, at least about 5 mg / mL, at least about 6 mg / mL, at least about 7 mg / mL, at least about 8 mg / mL, at least about 9 mg / mL, at least about 10 mg / mL, at least about 11 mg / mL, at least about 12 mg / mL, at least about 13 mg / mL, at least about 14 mg / mL, at least about 14.7 mg / ml, at least about 15 mg / mL, at least about 16 mg / mL, at least about 17 mg / mL, at least about 18 mg / mL, at least about 19 mg / mL, at least about 20 mg / mL, at least about 25 mg / mL, at least about 30 mg / mL, at least about 35 mg / mL, at least about 40 mg / mL, at least about 45 mg / mL, at least about 50 mg / mL, at least about 55 mg / mL, at least about 60 mg / mL, at least about 65 mg / mL, at least about 70 mg / mL, at least about 75 mg / mL, at least about 80 mg / mL, at least about 85 mg / mL, at least about 90 mg / mL, at least about 100 mg / mL, at least about 110 mg / mL, at least about 120 mg / mL, at least about 130 mg / mL, at least about 140 mg / mL, at least about 150 mg / mL, at least about 160 mg / mL, at least about 170 mg / mL, at least about 180 mg / mL, at least about 190 mg / mL, at least about 200 mg / mL, at least about 250 mg / mL, at least about 300 mg / mL, at least about 350 mg / mL, at least about 400 mg / mL, at least about 450 mg / mL, at least about 500 mg / mL, at least about 550 mg / mL, at least about 600 mg / mL, at least about 650 mg / mL, at least about 700 mg / mL, at least about 750 mg / mL, at least about 800 mg / mL, at least about 850 mg / mL, at least about 900 mg / mL, at least about 950 mg / mL, at least about 1,000 mg / mL, or more.

[0115] In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of at most about 1,000 mg / mL, at most about 950 mg / mL, at most about 900 mg / mL, at most about 850 mg / mL, at most about 800 mg / mL, at most about 750 mg / mL, at most about 700 mg / mL, at most about 650 mg / mL, at most about 600 mg / mL, at most about 550 mg / mL, at most about 500 mg / mL, at most about 450 mg / mL, at most about 400 mg / mL, at most about 350 mg / mL, at most about 300 mg / mL, at most about 250 mg / mL, at most about 200 mg / mL, at most about 190 mg / mL, at most about 180 mg / mL, at most about 170 mg / mL, at most about 160 mg / mL, at most about 150 mg / mL, at most about 140 mg / mL, at most about 130 mg / mL, at most about 120 mg / mL, at most about 110 mg / mL, at most about 100 mg / mL, at most about 95 mg / mL, at most about 90 mg / mL, at most about 85 mg / mL, at most about 80 mg / mL, at most about 75 mg / mL, at most about 70 mg / mL, at most about 65 mg / mL, at most about 60 mg / mL, at most about 55 mg / mL, at most about 50 mg / mL, at most about 45 mg / mL, at most about 40 mg / mL, at most about 35 mg / mL, at most about 30 mg / mL, at most about 25 mg / mL, at most about 20 mg / mL, at most about 19 mg / mL, at most about 18 mg / mL, at most about 17 mg / mL, at most about 16 mg / mL, at most about 15 mg / mL, at most about 14.7 mg / mL, at most about 14 mg / mL, at most about 13 mg / mL, at most about 12 mg / mL, at most about 11 mg / mL, at most about 10 mg / mL, at most about 9 mg / mL, at most about 8 mg / mL, at most about 7 mg / mL, at most about 6 mg / mL, at most about 5 mg / mL, at most about 4 mg / mL, at most about 3 mg / mL, at most about 2 mg / mL, at most about 1 mg / mL or less.

[0116] In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of from about 1 mg / mL to about 50 mg / mL, about 1 mg / mL to about 40 mg / mL, about 1 mg / mL to about 30 mg / mL, about 1 mg / mL to about 25 mg / mL, about 1 mg / mL to about 20 mg / mL, about 1 mg / mL to about 15 mg / mL, about 1 mg / mL to about 10 mg / mL, about 1 mg / mL to about 5 mg / mL, about 5 mg / mL to about 50 mg / mL, about 5 mg / mL to about 40 mg / mL, about 5 mg / mL to about 30 mg / mL, about 5 mg / mL to about 25 mg / mL, about 5 mg / mL to about 20 mg / mL, about 5 mg / mL to about 15 mg / mL, about 5 mg / mL to about 10 mg / mL, about 10 mg / mL to about 50 mg / mL, about 10 mg / mL to about 40 mg / mL, about 10 mg / mL to about 30 mg / mL, about 10 mg / mL to about 25 mg / mL, about 10 mg / mL to about 20 mg / mL, about 10 mg / mL to about 15 mg / mL, about 15 mg / mL to about 50 mg / mL, about 15 mg / mL to about 40 mg / mL, about 15 mg / mL to about 30 mg / mL, about 15 mg / mL to about 25 mg / mL, about 15 mg / mL to about 20 mg / mL, about 20 mg / mL to about 50 mg / mL, about 20 mg / mL to about 40 mg / mL, about 20 mg / mL to about 30 mg / mL, about 20 mg / mL to about 25 mg / mL, about 25mg / mL to about 50 mg / mL, about 25 mg / mL to about 40 mg / mL, about 25 mg / mL to about 30 mg / mL, about 30 mg / mL to about 50 mg / mL, about 30 mg / mL to about 40 mg / mL, or about 40 mg / mL to about 50 mg / mL.

[0117] In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in a dosage form. In some embodiments, testosterone or a testosterone derivative is provided in an amount of at least about 1 milligrams (mg), at least about 2 mg, at least about 3 mg, at least about 4 mg, at least about 5 mg, at least about 6 mg, at least about 7 mg, at least about 8 mg, at least about 9 mg, at least about 10 mg, at least about 11 mg, at least about 12 mg, at least about 13 mg, at least about 14 mg, at least about 15 mg, at least about 20 mg, at least about 25 mg, at least about 30 mg, at least about 35 mg, at least about 36.9 mg, at least about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 73.8 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 110 mg, at least about 120 mg, at least about 130 mg, at least about 140 mg, at least about 150 mg, at least about 160 mg, at least about 170 mg, at least about 180 mg, at least about 190 mg, at least about 200 mg, at least about 210 mg, at least about 220 mg, at least about 230 mg, at least about 240 mg, at least about 250 mg, at least about 260 mg, at least about 270 mg, at least about 280 mg, at least about 290 mg, at least about 300 mg, at least about 310 mg, at least about 320 mg, at least about 330 mg, at least about 340 mg, at least about 350 mg, at least about 360 mg, at least about 370 mg, at least about 380 mg, at least about 390 mg, at least about 400 mg, at least about 410 mg, at least about 420 mg, at least about 430 mg, at least about 440 mg, at least about 450 mg, at least about 460 mg, at least about 470 mg, at least about 480 mg, at least about 490 mg, at least about 500 mg, at least about 510 mg, at least about 520 mg, at least about 530 mg, at least about 540 mg, at least about 550 mg, at least about 560 mg, at least about 570 mg, at least about 580 mg, at least about 590 mg, at least about 600 mg, at least about 610 mg, at least about 620 mg, at least about 630 mg, at least about 640 mg, at least about 650 mg, at least about 660 mg, at least about 670 mg, at least about 680 mg, at least about 690 mg, at least about 700 mg, at least about 710 mg, at least about 720 mg, at least about 730 mg, at least about 740 mg, at least about 750 mg, at least about 760 mg, at least about 770 mg, at least about 780 mg, at least about 790 mg, at least about 800 mg, at least about 810 mg, at least about 820 mg, at least about 830 mg, at least about 840 mg, at least about 850 mg, at least about 860 mg, at least about 870 mg, at least about 880 mg, at least about 890 mg, at least about 900 mg, at leastabout 910 mg, at least about 920 mg, at least about 930 mg, at least about 940 mg, at least about 950 mg, at least about 960 mg, at least about 970 mg, at least about 980 mg, at least about 990 mg, at least about 1,000 mg, at least about 1,050 mg, at least about 1,100 mg, at least about 1,150 mg, at least about 1,200 mg, at least about 1,250 mg, at least about 1,300 mg, at least about 1,350 mg, at least about 1,400 mg, at least about 1,450 mg, at least about 1,500 mg, at least about 1,550 mg, at least about 1,600 mg, at least about 1,650 mg, at least about 1,700 mg, at least about 1,750 mg, at least about 1,800 mg, at least about 1,850 mg, at least about 1,900 mg, at least about 1,950 mg, at least about 2,000 mg, at least about 2,100 mg, at least about 2,200 mg, at least about 2,300 mg, at least about 2,400 mg, at least about 2,500 mg, at least about 2,600 mg, at least about 2,700 mg, at least about 2,800 mg, at least about 2,900 mg, at least about 3,000 mg, at least about 3,500 mg, at least about 4,000 mg, at least about 4,500 mg, at least about 5,000 mg, or more.

[0118] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at most about 5,000 mg, at most about 4,500 mg, at most about 4,000 mg, at most about 3,500 mg, at most about 3,000 mg, at most about 2,900 mg, at most about 2,800 mg, at most about 2,700 mg, at most about 2,600 mg, at most about 2,500 mg, at most about 2,400 mg, at most about 2,300 mg, at most about 2,200 mg, at most about 2,100 mg, at most about 2,000 mg, at most about 1,950 mg, at most about 1,900 mg, at most about 1,850 mg, at most about 1,800 mg, at most about 1,750 mg, at most about 1,700 mg, at most about 1,650 mg, at most about 1,600 mg, at most about 1,550 mg, at most about 1,500 mg, at most about 1,450 mg, at most about 1,400 mg, at most about 1,350 mg, at most about 1,300 mg, at most about 1,250 mg, at most about 1,200 mg, at most about 1,150 mg, at most about 1,100 mg, at most about 1,050 mg, at most about 1,000 mg, at most about 990 mg, at most about 980 mg, at most about 970 mg, at most about 960 mg, at most about 950 mg, at most about 940 mg, at most about 930 mg, at most about 920 mg, at most about 910 mg, at most about 900 mg, at most about 890 mg, at most about 880 mg, at most about 870 mg, at most about 860 mg, at most about 850 mg, at most about 840 mg, at most about 830 mg, at most about 820 mg, at most about 810 mg, at most about 800 mg, at most about 790 mg, at most about 780 mg, at most about 770 mg, at most about 760 mg, at most about 750 mg, at most about 740 mg, at most about 730 mg, at most about 720 mg, at most about 710 mg, at most about 700 mg, at most about 690 mg, at most about 680 mg, at most about 670 mg, at most about 660 mg, at most about 650 mg, at most about 640 mg, at most about 630 mg, at most about 620 mg, at most about 610 mg, at most about 600 mg, at most about 590 mg, at most about 580 mg, at most about 570 mg, at most about 560 mg, at most about 550 mg, at most about 540 mg, at most about 530 mg, at mostabout 520 mg, at most about 510 mg, at most about 500 mg, at most about 490 mg, at most about 480 mg, at most about 470 mg, at most about 460 mg, at most about 450 mg, at most about 440 mg, at most about 430 mg, at most about 420 mg, at most about 410 mg, at most about 400 mg, at most about 390 mg, at most about 380 mg, at most about 370 mg, at most about 360 mg, at most about 350 mg, at most about 340 mg, at most about 330 mg, at most about 320 mg, at most about 310 mg, at most about 300 mg, at most about 290 mg, at most about 280 mg, at most about 270 mg, at most about 260 mg, at most about 250 mg, at most about 240 mg, at most about 230 mg, at most about 220 mg, at most about 210 mg, at most about 200 mg, at most about 190 mg, at most about 180 mg, at most about 170 mg, at most about 160 mg, at most about 150 mg, at most about 140 mg, at most about 130 mg, at most about 120 mg, at most about 110 mg, at most about 100 mg, at most about 95 mg, at most about 90 mg, at most about 85 mg, at most about 80 mg, at most about 75 mg, at most about 73.8, at most about 70 mg, at most about 65 mg, at most about 60 mg, at most about 55 mg, at most about 50 mg, at most about 45 mg, at most about 40 mg, at most about 36.39 mg, at most about 35 mg, at most about 30 mg, at most about 25 mg, at most about 20 mg, at most about 15 mg, at most about 14 mg, at most about 13 mg, at most about 12 mg, at most about 11 mg, at most about 10 mg, at most about 9 mg, at most about 8 mg, at most about 7 mg, at most about 6 mg, at most about 5 mg, at most about 4 mg, at most about 3 mg, at most about 2 mg, at most about 1 mg, or less.

[0119] In some embodiments, testosterone or a testosterone derivative is provided in an amount of from about 1 mg to about 400 mg, about 1 mg to about 300 mg, about 1 mg to about 250 mg, about 1 mg to about 200 mg, about 1 mg to about 150 mg, about 1 mg to about 100 mg, about 1 mg to about 90 mg, about 1 mg to about 80 mg, about 1 mg to about 50 mg, about 1 mg to about 20 mg, about 20 mg to about 400 mg, about 20 mg to about 300 mg, about 20 mg to about 250 mg, about 20 mg to about 200 mg, about 20 mg to about 150 mg, about 20 mg to about 100 mg, about 20 mg to about 90 mg, about 20 mg to about 80 mg, about 20 mg to about 50 mg, about 20 mg to about 40 mg, about 30 mg to about 40 mg, about 40 mg to about 80 mg; about 50 mg to about 80 mg; about 50 mg to about 300 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, about 50 mg to about 100 mg, about 50 mg to about 90 mg, about 50 mg to about 80 mg, about 60 mg to about 80 mg, about 70 mg to about 80 mg, or about 300 mg to about 400 mg.

[0120] In some embodiments, testosterone or a testosterone derivative is provided in an amount of 73.8 mg. In some embodiments, testosterone or a testosterone derivative isprovided in an amount of 36.39 mg. In some embodiments, testosterone or a testosterone derivative is provided in an amount of 62.4 mg.

[0121] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at least about 1 mg / g at least about 2 mg / g, at least about 3 mg / g, at least about 4 mg / g, at least about 5 mg / g, at least about 6 mg / g, at least about 7 mg / g, at least about 8 mg / g, at least about 9 mg / g, at least about 10 mg / g, at least about 11 mg / g, at least about 12 mg / g, at least about 13 mg / g, at least about 14 mg / g, at least about 15 mg / g, at least about 20 mg / g, at least about 25 mg / g, at least about 30 mg / g, at least about 35 mg / g, at least about 40 mg / g, at least about 45 mg / g, at least about 50 mg / g, at least about 55 mg / g, at least about 60 mg / g, at least about 65 mg / g, at least about 70 mg / g, at least about 75 mg / g, at least about 80 mg / g, at least about 85 mg / g, at least about 90 mg / g, at least about 95 mg / g, at least about 100 mg / g, at least about 110 mg / g, at least about 120 mg / g, at least about 130 mg / g, at least about 140 mg / g, at least about 150 mg / g, at least about 160 mg / g, at least about 170 mg / g, at least about 180 mg / g, at least about 190 mg / g, at least about 200 mg / g, at least about 210 mg / g, at least about 220 mg / g, at least about 230 mg / g, at least about 240 mg / g, at least about 250 mg / g, at least about 260 mg / g, at least about 270 mg / g, at least about 280 mg / g, at least about 290 mg / g, at least about 300 mg / g, at least about 310 mg / g, at least about 320 mg / g, at least about 330 mg / g, at least about 340 mg / g, at least about 350 mg / g, at least about 360 mg / g, at least about 370 mg / g, at least about 380 mg / g, at least about 390 mg / g, at least about 400 mg / g, at least about 410 mg / g, at least about 420 mg / g, at least about 430 mg / g, at least about 440 mg / g, at least about 450 mg / g, at least about 460 mg / g, at least about 470 mg / g, at least about 480 mg / g, at least about 490 mg / g, at least about 500 mg / g, at least about 510 mg / g, at least about 520 mg / g, at least about 530 mg / g, at least about 540 mg / g, at least about 550 mg / g, at least about 560 mg / g, at least about 570 mg / g, at least about 580 mg / g, at least about 590 mg / g, at least about 600 mg / g, at least about 610 mg / g, at least about 620 mg / g, at least about 630 mg / g, at least about 640 mg / g, at least about 650 mg / g, at least about 660 mg / g, at least about 670 mg / g, at least about 680 mg / g, at least about 690 mg / g, at least about 700 mg / g, at least about 710 mg / g, at least about 720 mg / g, at least about 730 mg / g, at least about 740 mg / g, at least about 750 mg / g, at least about 760 mg / g, at least about 770 mg / g, at least about 780 mg / g, at least about 790 mg / g, at least about 800 mg / g, at least about 810 mg / g, at least about 820 mg / g, at least about 830 mg / g, at least about 840 mg / g, at least about 850 mg / g, at least about 860 mg / g, at least about 870 mg / g, at least about 880 mg / g, at least about 890 mg / g, at least about 900 mg / g, at least about 910 mg / g, at least about 920 mg / g, at least about 930 mg / g, at least about 940 mg / g, at least about 950 mg / g, at least about 960 mg / g, at least about 970 mg / g, at least about 980 mg / g, at least about 990 mg / g, at least about 1,000 mg / g, at least about 1,050 mg / g, at least about 1,100 mg / g,at least about 1,150 mg / g, at least about 1,200 mg / g, at least about 1,250 mg / g, at least about 1,300 mg / g, at least about 1,350 mg / g, at least about 1,400 mg / g, at least about 1,450 mg / g, at least about 1,500 mg / g, at least about 1,550 mg / g, at least about 1,600 mg / g, at least about 1,650 mg / g, at least about 1,700 mg / g, at least about 1,750 mg / g, at least about 1,800 mg / g, at least about 1,850 mg / g, at least about 1,900 mg / g, at least about 1,950 mg / g, at least about 2,000 mg / g, at least about 2,100 mg / g, at least about 2,200 mg / g, at least about 2,300 mg / g, at least about 2,400 mg / g, at least about 2,500 mg / g, at least about 2,600 mg / g, at least about 2,700 mg / g, at least about 2,800 mg / g, at least about 2,900 mg / g, at least about 3,000 mg / g, at least about 3,500 mg / g, at least about 4,000 mg / g, at least about 4,500 mg / g, at least about 5,000 mg / g, or more.

[0122] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at most about 5,000 mg / g, at most about 4,500 mg / g, at most about 4,000 mg / g, at most about 3,500 mg / g, at most about 3,000 mg / g, at most about 2,900 mg / g, at most about 2,800 mg / g, at most about 2,700 mg / g, at most about 2,600 mg / g, at most about 2,500 mg / g, at most about 2,400 mg / g, at most about 2,300 mg / g, at most about 2,200 mg / g, at most about 2,100 mg / g, at most about 2,000 mg / g, at most about 1,950 mg / g, at most about 1,900 mg / g, at most about 1,850 mg / g, at most about 1,800 mg / g, at most about 1,750 mg / g, at most about 1,700 mg / g, at most about 1,650 mg / g, at most about 1,600 mg / g, at most about 1,550 mg / g, at most about 1,500 mg / g, at most about 1,450 mg / g, at most about 1,400 mg / g, at most about 1,350 mg / g, at most about 1,300 mg / g, at most about 1,250 mg / g, at most about 1,200 mg / g, at most about 1,150 mg / g, at most about 1,100 mg / g, at most about 1,050 mg / g, at most about 1,000 mg / g, at most about 990 mg / g, at most about 980 mg / g, at most about 970 mg / g, at most about 960 mg / g, at most about 950 mg / g, at most about 940 mg / g, at most about 930 mg / g, at most about 920 mg / g, at most about 910 mg / g, at most about 900 mg / g, at most about 890 mg / g, at most about 880 mg / g, at most about 870 mg / g, at most about 860 mg / g, at most about 850 mg / g, at most about 840 mg / g, at most about 830 mg / g, at most about 820 mg / g, at most about 810 mg / g, at most about 800 mg / g, at most about 790 mg / g, at most about 780 mg / g, at most about 770 mg / g, at most about 760 mg / g, at most about 750 mg / g, at most about 740 mg / g, at most about 730 mg / g, at most about 720 mg / g, at most about 710 mg / g, at most about 700 mg / g, at most about 690 mg / g, at most about 680 mg / g, at most about 670 mg / g, at most about 660 mg / g, at most about 650 mg / g, at most about 640 mg / g, at most about 630 mg / g, at most about 620 mg / g, at most about 610 mg / g, at most about 600 mg / g, at most about 590 mg / g, at most about 580 mg / g, at most about 570 mg / g, at most about 560 mg / g, at most about 550 mg / g, at most about 540 mg / g, at most about 530 mg / g, at most about 520 mg / g, at most about 510 mg / g, at most about 500 mg / g, at most about 490 mg / g, at most about 480 mg / g, at most about 470mg / g, at most about 460 mg / g, at most about 450 mg / g, at most about 440 mg / g, at most about 430 mg / g, at most about 420 mg / g, at most about 410 mg / g, at most about 400 mg / g, at most about 390 mg / g, at most about 380 mg / g, at most about 370 mg / g, at most about 360 mg / g, at most about 350 mg / g, at most about 340 mg / g, at most about 330 mg / g, at most about 320 mg / g, at most about 310 mg / g, at most about 300 mg / g, at most about 290 mg / g, at most about 280 mg / g, at most about 270 mg / g, at most about 260 mg / g, at most about 250 mg / g, at most about 240 mg / g, at most about 230 mg / g, at most about 220 mg / g, at most about 210 mg / g, at most about 200 mg / g, at most about 190 mg / g, at most about 180 mg / g, at most about 170 mg / g, at most about 160 mg / g, at most about 150 mg / g, at most about 140 mg / g, at most about 130 mg / g, at most about 120 mg / g, at most about 110 mg / g, at most about 100 mg / g, at most about 95 mg / g, at most about 90 mg / g, at most about 85 mg / g, at most about 80 mg / g, at most about 75 mg / g, at most about 70 mg / g, at most about 65 mg / g, at most about 60 mg / g, at most about 55 mg / g, at most about 50 mg / g, at most about 45 mg / g, at most about 40 mg / g, at most about 35 mg / g, at most about 30 mg / g, at most about 25 mg / g, at most about 20 mg / g, at most about 15 mg / g, at most about 14 mg / g, at most about 13 mg / g, at most about 12 mg / g, at most about 11 mg / g, at most about 10 mg / g, at most about 9 mg / g, at most about 8 mg / g, at most about 7 mg / g, at most about 6 mg / g, at most about 5 mg / g, at most about 4 mg / g, at most about 3 mg / g, at most about 2 mg / g, at most about 1 mg / g, or less.

[0123] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0. 1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1.5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4. 1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7.1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8. 1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9.1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 1 1% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0124] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at mostabout 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2. 1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0125] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at least about 0.001% weight by weight (wt / wt), at least about 0.002% wt / wt, at least about 0.003% wt / wt, at least about 0.004% wt / wt, at least about 0.005% wt / wt, at least about 0.006% wt / wt, at least about 0.007% wt / wt, at least about 0.008% wt / wt, at least about 0.009% wt / wt, at least about 0.01% wt / wt, at least about 0.02% wt / wt, at least about 0.03% wt / wt, at least about 0.04% wt / wt, at least about 0.05% wt / wt, at least about 0.06% wt / wt, at least about 0.07% wt / wt, at least about 0.08% wt / wt, at least about 0.09% wt / wt, at least about 0.1% wt / wt, at least about 0.2% wt / wt, at least about 0.3% wt / wt, at least about 0.4% wt / wt, at least about 0.5% wt / wt, at least about 0.6% wt / wt, at least about 0.7% wt / wt, at least about 0.8% wt / wt, at least about 0.9% wt / wt, at least about 1.0% wt / wt, at least about 1.1% wt / wt, at least about 1.2% wt / wt, at least about 1.3% wt / wt, at least about 1.4% wt / wt, at least about 1.5% wt / wt, at least about 1.6% wt / wt, at least about 1.697% wt / wt, at least about 1.7% wt / wt, at least about 1.8% wt / wt, at least about 1.9% wt / wt, at least about 2.0% wt / wt, at least about 2.1% wt / wt, at least about 2.2% wt / wt, at least about 2.3% wt / wt, at least about 2.4% wt / wt, at least about 2.5% wt / wt, at least about 2.6% wt / wt, at least about 2.7% wt / wt, at least about 2.8% wt / wt, at least about 2.9% wt / wt, at least about 3.0% wt / wt, at least about 3.1% wt / wt, at least about 3.2% wt / wt, at least about 3.3% wt / wt, at least about 3.4% wt / wt, at least about 3.5% wt / wt, at least about 3.6% wt / wt, at least about 3.7% wt / wt, at least about 3.8% wt / wt, at least about 3.9% wt / wt, at least about 4.0% wt / wt, at least about 4.1% wt / wt, at least about 4.2% wt / wt, at least about 4.3% wt / wt, at least about 4.4% wt / wt, at least about 4.5% wt / wt, at least about 4.6% wt / wt, at least about 4.7% wt / wt, at least about 4.8% wt / wt, at least about 4.9% wt / wt, at least about 5.0% wt / wt, at least about 5.1% wt / wt, at least about 5.2% wt / wt, at least about 5.3% wt / wt, at least about 5.4% wt / wt, at least about 5.5% wt / wt, at least about 5.6% wt / wt, at least about 5.7% wt / wt, at least about 5.8% wt / wt, at least about 5.9% wt / wt, at least about 6.0% wt / wt, at least about 6.1% wt / wt, at least about 6.2% wt / wt, at least about 6.3% wt / wt, at least about 6.4% wt / wt, at least about 6.5% wt / wt, at least about 6.6% wt / wt, at least about 6.7% wt / wt, at least about 6.8% wt / wt, at least about 6.9% wt / wt, at least about 7.0% wt / wt, at least about 7.1% wt / wt, at least about 7.2% wt / wt, at least about 7.3% wt / wt, at least about 7.4% wt / wt, at least about 7.5% wt / wt, at least about 7.6% wt / wt, at least about 7.7% wt / wt, at least about 7.8% wt / wt, at least about 7.9% wt / wt, at least about 8.0%wt / wt, at least about 8.1% wt / wt, at least about 8.2% wt / wt, at least about 8.3% wt / wt, at least about 8.4% wt / wt, at least about 8.5% wt / wt, at least about 8.6% wt / wt, at least about 8.7% wt / wt, at least about 8.8% wt / wt, at least about 8.9% wt / wt, at least about 9.0% wt / wt, at least about 9.1% wt / wt, at least about 9.2% wt / wt, at least about 9.3% wt / wt, at least about 9.4% wt / wt, at least about 9.5% wt / wt, at least about 9.6% wt / wt, at least about 9.7% wt / wt, at least about 9.8% wt / wt, at least about 9.9% wt / wt, at least about 10% wt / wt, at least about 11% wt / wt, at least about 12% wt / wt, at least about 13% wt / wt, at least about 14% wt / wt, at least about 15% wt / wt, at least about 16% wt / wt, at least about 17% wt / wt, at least about 18% wt / wt, at least about 19% wt / wt, at least about 20% wt / wt, at least about 21% wt / wt, at least about 22% wt / wt, at least about 23% wt / wt, at least about 24% wt / wt, at least about 25% wt / wt, at least about 30% wt / wt, at least about 35% wt / wt, at least about 40% wt / wt, at least about 45% wt / wt, at least about 50% wt / wt, at least about 55% wt / wt, at least about 60% wt / wt, at least about 65% wt / wt, at least about 70% wt / wt, at least about 75% wt / wt, at least about 80% wt / wt, at least about 85% wt / wt, at least about 90% wt / wt, at least about 91% wt / wt, at least about 92% wt / wt, at least about 93% wt / wt, at least about 94% wt / wt, at least about 95% wt / wt, at least about 96% wt / wt, at least about 97% wt / wt, at least about 98% wt / wt, at least about 99% wt / wt, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc ).

[0126] In some embodiments, testosterone or a testosterone derivative is provided in an amount of at most about 99% wt / wt, at most about 98% wt / wt, at most about 97% wt / wt, at most about 96% wt / wt, at most about 95% wt / wt, at most about 94% wt / wt, at most about 93% wt / wt, at most about 92% wt / wt, at most about 91% wt / wt, at most about 90% wt / wt, at most about 85% wt / wt, at most about 80% wt / wt, at most about 75% wt / wt, at most about 70% wt / wt, at most about 65% wt / wt, at most about 60% wt / wt, at most about 55% wt / wt, at most about 50% wt / wt, at most about 45% wt / wt, at most about 40% wt / wt, at most about 35% wt / wt, at most about 30% wt / wt, at most about 25% wt / wt, at most about 24% wt / wt, at most about 23% wt / wt, at most about 22% wt / wt, at most about 21% wt / wt, at most about 20% wt / wt, at most about 19% wt / wt, at most about 18% wt / wt, at most about 17% wt / wt, at most about 16% wt / wt, at most about 15% wt / wt, at most about 14% wt / wt, at most about 13% wt / wt, at most about 12% wt / wt, at most about 1 1% wt / wt, at most about 10% wt / wt, at most about 9.9% wt / wt, at most about 9.8% wt / wt, at most about 9.7% wt / wt, at most about 9.6% wt / wt, at most about 9.5% wt / wt, at most about 9.4% wt / wt, at most about 9.3% wt / wt, at most about 9.2% wt / wt, at most about 9.1% wt / wt, at most about 9.0% wt / wt, at most about 8.9% wt / wt, at most about 8.8% wt / wt, at most about 8.7% wt / wt, at most about 8.6% wt / wt, at most about 8.5% wt / wt, at most about 8.4% wt / wt, at mostabout 8.3% wt / wt, at most about 8.2% wt / wt, at most about 8.1% wt / wt, at most about 8.0% wt / wt, at most about 7.9% wt / wt, at most about 7.8% wt / wt, at most about 7.7% wt / wt, at most about 7.6% wt / wt, at most about 7.5% wt / wt, at most about 7.4% wt / wt, at most about 7.3% wt / wt, at most about 7.2% wt / wt, at most about 7.1% wt / wt, at most about 7.0% wt / wt, at most about 6.9% wt / wt, at most about 6.8% wt / wt, at most about 6.7% wt / wt, at most about 6.6% wt / wt, at most about 6.5% wt / wt, at most about 6.4% wt / wt, at most about 6.3% wt / wt, at most about 6.2% wt / wt, at most about 6.1% wt / wt, at most about 6.0% wt / wt, at most about 5.9% wt / wt, at most about 5.8% wt / wt, at most about 5.7% wt / wt, at most about 5.6% wt / wt, at most about 5.5% wt / wt, at most about 5.4% wt / wt, at most about 5.3% wt / wt, at most about 5.2% wt / wt, at most about 5.1% wt / wt, at most about 5.0% wt / wt, at most about 4.9% wt / wt, at most about 4.8% wt / wt, at most about 4.7% wt / wt, at most about 4.6% wt / wt, at most about 4.5% wt / wt, at most about 4.4% wt / wt, at most about 4.3% wt / wt, at most about 4.2% wt / wt, at most about 4.1% wt / wt, at most about 4.0% wt / wt, at most about 3.9% wt / wt, at most about 3.8% wt / wt, at most about 3.7% wt / wt, at most about 3.6% wt / wt, at most about 3.5% wt / wt, at most about 3.4% wt / wt, at most about 3.3% wt / wt, at most about 3.2% wt / wt, at most about 3.1% wt / wt, at most about 3.0% wt / wt, at most about 2.9% wt / wt, at most about 2.8% wt / wt, at most about 2.7% wt / wt, at most about 2.6% wt / wt, at most about 2.5% wt / wt, at most about 2.4% wt / wt, at most about 2.3% wt / wt, at most about 2.2% wt / wt, at most about 2.1% wt / wt, at most about 2.0% wt / wt, at most about 1.9% wt / wt, at most about 1.8% wt / wt, at most about 1.7% wt / wt, at most about 1.697% wt / wt, at most about 1.6% wt / wt, at most about 1.5% wt / wt, at most about 1.4% wt / wt, at most about 1.3% wt / wt, at most about 1.2% wt / wt, at most about 1.1% wt / wt, at most about 1.0% wt / wt, at most about 0.9% wt / wt, at most about 0.8% wt / wt, at most about 0.7% wt / wt, at most about 0.6% wt / wt, at most about 0.5% wt / wt, at most about 0.4% wt / wt, at most about 0.3% wt / wt, at most about 0.2% wt / wt, at most about 0.1% wt / wt, at most about 0.09% wt / wt, at most about 0.08% wt / wt, at most about 0.07% wt / wt, at most about 0.06% wt / wt, at most about 0.05% wt / wt, at most about 0.04% wt / wt, at most about 0.03% wt / wt, at most about 0.02% wt / wt, at most about 0.01% wt / wt, at most about 0.009% wt / wt, at most about 0.008% wt / wt, at most about 0.007% wt / wt, at most about 0.006% wt / wt, at most about 0.005% wt / wt, at most about 0.004% wt / wt, at most about 0.003% wt / wt, at most about 0.002% wt / wt, at most about 0.001% wt / wt, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0127] In some embodiments, testosterone or a testosterone derivative is provided in an amount of from about 0.1% wt / wt to about 5% wt / wt, about 0.1% wt / wt to about 4.5% wt / wt,about 0.1% wt / wt to about 4% wt / wt, about 0.1% wt / wt to about 3.5% wt / wt, about 0.1% wt / wt to about 3% wt / wt, about 0.1% wt / wt to about 2.5% wt / wt, about 0.1% wt / wt to about 2% wt / wt, about 0.1% wt / wt to about 1.5% wt / wt, about 0.1% wt / wt to about 1% wt / wt, about 0.1% wt / wt to about 0.5% wt / wt, about 0.5% wt / wt to about 5% wt / wt, about 0.5% wt / wt to about 4.5% wt / wt, about 0.5% wt / wt to about 4% wt / wt, 0.5% wt / wt to about 3.5% wt / wt, 0.5% wt / wt to about 3% wt / wt, 0.5% wt / wt to about 2.5% wt / wt, about 0.5% wt / wt to about 2% wt / wt, about 0.5% wt / wt to about 1.5% wt / wt, about 0.5% wt / wt to about 1% wt / wt, about 1% wt / wt to about 5% wt / wt, about 1% wt / wt to about 4.5% wt / wt, about 1% wt / wt to about 4% wt / wt, about 1% wt / wt to about 3.5% wt / wt, about 1% wt / wt to about 3% wt / wt, about 1% wt / wt to about 2.5% wt / wt, about 1% wt / wt to about 2% wt / wt, or about 1% wt / wt to about 1.5% wt / wt.

[0128] In some embodiments, testosterone or a testosterone derivative is provided in an amount of 1.6% wt / wt. In some embodiments, testosterone or a testosterone derivative is provided in an amount of 1.697% wt / wt. In some embodiments, testosterone or a testosterone derivative is provided in an amount of 1.7% wt / wt.

[0129] In some embodiments, testosterone, a testosterone derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in a gaseous dosage form. The gaseous dosage form can be useful for use inhalation by a subject.

[0130] In some embodiments, a pharmaceutical composition as disclosed herein can comprise a progesterone, a progesterone derivative, a pharmaceutically-acceptable salt thereof, or a combination thereof. In some embodiments, a pharmaceutical composition can comprise a therapeutically-effective amount of progesterone or a progesterone derivative.

[0131] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically acceptable salt thereof as described herein can be administered in a dosage form. In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically- acceptable salt thereof is present in a formulation in an amount of at least about 1 milligram per milliliter (mg / mL), at least about 1.6 mg / mL, at least about 2 mg / mL, at least about 3 mg / mL, at least about 4 mg / mL, at least about 5 mg / mL, at least about 6 mg / mL, at least about 7 mg / mL, at least about 8 mg / mL, at least about 9 mg / mL, at least about 10 mg / mL, at least about 11 mg / mL, at least about 12 mg / mL, at least about 13 mg / mL, at least about 14 mg / mL, at least about 15 mg / mL, at least about 16 mg / mL, at least about 17 mg / mL, at least about 18 mg / mL, at least about 19 mg / mL, at least about 20 mg / mL, at least about 25 mg / mL, at least about 30 mg / mL, at least about 35 mg / mL, at least about 40 mg / mL, at least about 45 mg / mL, at least about 50 mg / mL, at least about 55 mg / mL, at least about 60 mg / mL, at least about 65 mg / mL, at leastabout 70 mg / mL, at least about 75 mg / mL, at least about 80 mg / mL, at least about 85 mg / mL, at least about 90 mg / mL, at least about 100 mg / mL, at least about 110 mg / mL, at least about 120 mg / mL, at least about 130 mg / mL, at least about 140 mg / mL, at least about 150 mg / mL, at least about 160 mg / mL, at least about 170 mg / mL, at least about 180 mg / mL, at least about 190 mg / mL, at least about 200 mg / mL, at least about 250 mg / mL, at least about 300 mg / mL, at least about 350 mg / mL, at least about 400 mg / mL, at least about 450 mg / mL, at least about 500 mg / mL, at least about 550 mg / mL, at least about 600 mg / mL, at least about 650 mg / mL, at least about 700 mg / mL, at least about 750 mg / mL, at least about 800 mg / mL, at least about 850 mg / mL, at least about 900 mg / mL, at least about 950 mg / mL, at least about 1,000 mg / mL, or more.

[0132] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of at most about 1,000 mg / mL, at most about 950 mg / mL, at most about 900 mg / mL, at most about 850 mg / mL, at most about 800 mg / mL, at most about 750 mg / mL, at most about 700 mg / mL, at most about 650 mg / mL, at most about 600 mg / mL, at most about 550 mg / mL, at most about 500 mg / mL, at most about 450 mg / mL, at most about 400 mg / mL, at most about 350 mg / mL, at most about 300 mg / mL, at most about 250 mg / mL, at most about 200 mg / mL, at most about 190 mg / mL, at most about 180 mg / mL, at most about 170 mg / mL, at most about 160 mg / mL, at most about 150 mg / mL, at most about 140 mg / mL, at most about 130 mg / mL, at most about 120 mg / mL, at most about 110 mg / mL, at most about 100 mg / mL, at most about 95 mg / mL, at most about 90 mg / mL, at most about 85 mg / mL, at most about 80 mg / mL, at most about 75 mg / mL, at most about 70 mg / mL, at most about 65 mg / mL, at most about 60 mg / mL, at most about 55 mg / mL, at most about 50 mg / mL, at most about 45 mg / mL, at most about 40 mg / mL, at most about 35 mg / mL, at most about 30 mg / mL, at most about 25 mg / mL, at most about 20 mg / mL, at most about 19 mg / mL, at most about 18 mg / mL, at most about 17 mg / mL, at most about 16 mg / mL, at most about 15 mg / mL, at most about 14 mg / mL, at most about 13 mg / mL, at most about 12 mg / mL, at most about 11 mg / mL, at most about 10 mg / mL, at most about 9 mg / mL, at most about 8 mg / mL, at most about 7 mg / mL, at most about 6 mg / mL, at most about 5 mg / mL, at most about 4 mg / mL, at most about 3 mg / mL, at most about 2 mg / mL, at most about 1 mg / mL or less.

[0133] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of from about 1 mg / mL to about 50 mg / mL, about 1 mg / mL to about 40 mg / mL, about 1 mg / mL to about 30 mg / mL, about 1 mg / mL to about 25 mg / mL, about 1 mg / mL to about 20 mg / mL, about 1mg / mL to about 15 mg / mL, about 1 mg / mL to about 10 mg / mL, about 1 mg / mL to about 5 mg / mL, about 1 mg / mL to about 4 mg / mL, about 1 mg / mL to about 3 mg / mL, about 1 mg / mL to about 2 mg / mL, about 2 mg / mL to about 5 mg / mL, about 2 mg / mL to about 4 mg / mL, about 2 mg / mL to about 3 mg / mL, about 3 mg / mL to about 5 mg / mL, about 4 mg / mL to about 5 mg / mL, about 5 mg / mL to about 50 mg / mL, about 5 mg / mL to about 40 mg / mL, about 5 mg / mL to about 30 mg / mL, about 5 mg / mL to about 25 mg / mL, about 5 mg / mL to about 20 mg / mL, about 5 mg / mL to about 15 mg / mL, about 5 mg / mL to about 10 mg / mL, about 10 mg / mL to about 50 mg / mL, about 10 mg / mL to about 40 mg / mL, about 10 mg / mL to about 30 mg / mL, about 10 mg / mL to about 25 mg / mL, about 10 mg / mL to about 20 mg / mL, about 10 mg / mL to about 15 mg / mL, about 15 mg / mL to about 50 mg / mL, about 15 mg / mL to about 40 mg / mL, about 15 mg / mL to about 30 mg / mL, about 15 mg / mL to about 25 mg / mL, about 15 mg / mL to about 20 mg / mL, about 20 mg / mL to about 50 mg / mL, about 20 mg / mL to about 40 mg / mL, about 20 mg / mL to about 30 mg / mL, about 20 mg / mL to about 25 mg / mL, about 25 mg / mL to about 50 mg / mL, about 25 mg / mL to about 40 mg / mL, about 25 mg / mL to about 30 mg / mL, about 30 mg / mL to about 50 mg / mL, about 30 mg / mL to about 40 mg / mL, or about 40 mg / mL to about 50 mg / mL.

[0134] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in a dosage form. In some embodiments, progesterone or a progesterone derivative is provided in an amount of at least about 1 milligrams (mg), at least about 2 mg, at least about 3 mg, at least about 4 mg, at least about 4. 1 mg, at least about 5 mg, at least about 6 mg, at least about 7 mg, at least about 8 mg, at least about 8.2 mg, at least about 9 mg, at least about 10 mg, at least about 11 mg, at least about 12 mg, at least about 13 mg, at least about 14 mg, at least about 15 mg, at least about 20 mg, at least about 25 mg, at least about 30 mg, at least about 35 mg, at least about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 110 mg, at least about 120 mg, at least about 130 mg, at least about 140 mg, at least about 150 mg, at least about 160 mg, at least about 170 mg, at least about 180 mg, at least about 190 mg, at least about 200 mg, at least about 210 mg, at least about 220 mg, at least about 230 mg, at least about 240 mg, at least about 250 mg, at least about 260 mg, at least about 270 mg, at least about 280 mg, at least about 290 mg, at least about 300 mg, at least about 310 mg, at least about 320 mg, at least about 330 mg, at least about 340 mg, at least about 350 mg, at least about 360 mg, at least about 370 mg, at least about 380 mg, at least about 390 mg, at least about 400 mg, at least about 410 mg, at leastabout 420 mg, at least about 430 mg, at least about 440 mg, at least about 450 mg, at least about 460 mg, at least about 470 mg, at least about 480 mg, at least about 490 mg, at least about 500 mg, at least about 510 mg, at least about 520 mg, at least about 530 mg, at least about 540 mg, at least about 550 mg, at least about 560 mg, at least about 570 mg, at least about 580 mg, at least about 590 mg, at least about 600 mg, at least about 610 mg, at least about 620 mg, at least about 630 mg, at least about 640 mg, at least about 650 mg, at least about 660 mg, at least about 670 mg, at least about 680 mg, at least about 690 mg, at least about 700 mg, at least about 710 mg, at least about 720 mg, at least about 730 mg, at least about 740 mg, at least about 750 mg, at least about 760 mg, at least about 770 mg, at least about 780 mg, at least about 790 mg, at least about 800 mg, at least about 810 mg, at least about 820 mg, at least about 830 mg, at least about 840 mg, at least about 850 mg, at least about 860 mg, at least about 870 mg, at least about 880 mg, at least about 890 mg, at least about 900 mg, at least about 910 mg, at least about 920 mg, at least about 930 mg, at least about 940 mg, at least about 950 mg, at least about 960 mg, at least about 970 mg, at least about 980 mg, at least about 990 mg, at least about 1,000 mg, at least about 1,050 mg, at least about 1,100 mg, at least about 1,150 mg, at least about 1,200 mg, at least about 1,250 mg, at least about 1,300 mg, at least about 1,350 mg, at least about 1,400 mg, at least about 1,450 mg, at least about 1,500 mg, at least about 1,550 mg, at least about 1,600 mg, at least about 1,650 mg, at least about 1,700 mg, at least about 1,750 mg, at least about 1,800 mg, at least about 1,850 mg, at least about 1,900 mg, at least about 1,950 mg, at least about 2,000 mg, at least about 2,100 mg, at least about 2,200 mg, at least about 2,300 mg, at least about 2,400 mg, at least about 2,500 mg, at least about 2,600 mg, at least about 2,700 mg, at least about 2,800 mg, at least about 2,900 mg, at least about 3,000 mg, at least about 3,500 mg, at least about 4,000 mg, at least about 4,500 mg, at least about 5,000 mg, or more.

[0135] In some embodiments, progesterone or a progesterone derivative is provided in an amount of at most about 5,000 mg, at most about 4,500 mg, at most about 4,000 mg, at most about 3,500 mg, at most about 3,000 mg, at most about 2,900 mg, at most about 2,800 mg, at most about 2,700 mg, at most about 2,600 mg, at most about 2,500 mg, at most about 2,400 mg, at most about 2,300 mg, at most about 2,200 mg, at most about 2,100 mg, at most about 2,000 mg, at most about 1,950 mg, at most about 1,900 mg, at most about 1,850 mg, at most about 1,800 mg, at most about 1,750 mg, at most about 1,700 mg, at most about 1,650 mg, at most about 1,600 mg, at most about 1,550 mg, at most about 1,500 mg, at most about 1,450 mg, at most about 1,400 mg, at most about 1,350 mg, at most about 1,300 mg, at most about 1,250 mg, at most about 1,200 mg, at most about 1,150 mg, at most about 1,100 mg, at most about 1,050 mg, at most about 1,000 mg, at most about 990 mg, at most about 980 mg, at most about 970mg, at most about 960 mg, at most about 950 mg, at most about 940 mg, at most about 930 mg, at most about 920 mg, at most about 910 mg, at most about 900 mg, at most about 890 mg, at most about 880 mg, at most about 870 mg, at most about 860 mg, at most about 850 mg, at most about 840 mg, at most about 830 mg, at most about 820 mg, at most about 810 mg, at most about 800 mg, at most about 790 mg, at most about 780 mg, at most about 770 mg, at most about 760 mg, at most about 750 mg, at most about 740 mg, at most about 730 mg, at most about 720 mg, at most about 710 mg, at most about 700 mg, at most about 690 mg, at most about 680 mg, at most about 670 mg, at most about 660 mg, at most about 650 mg, at most about 640 mg, at most about 630 mg, at most about 620 mg, at most about 610 mg, at most about 600 mg, at most about 590 mg, at most about 580 mg, at most about 570 mg, at most about 560 mg, at most about 550 mg, at most about 540 mg, at most about 530 mg, at most about 520 mg, at most about 510 mg, at most about 500 mg, at most about 490 mg, at most about 480 mg, at most about 470 mg, at most about 460 mg, at most about 450 mg, at most about 440 mg, at most about 430 mg, at most about 420 mg, at most about 410 mg, at most about 400 mg, at most about 390 mg, at most about 380 mg, at most about 370 mg, at most about 360 mg, at most about 350 mg, at most about 340 mg, at most about 330 mg, at most about 320 mg, at most about 310 mg, at most about 300 mg, at most about 290 mg, at most about 280 mg, at most about 270 mg, at most about 260 mg, at most about 250 mg, at most about 240 mg, at most about 230 mg, at most about 220 mg, at most about 210 mg, at most about 200 mg, at most about 190 mg, at most about 180 mg, at most about 170 mg, at most about 160 mg, at most about 150 mg, at most about 140 mg, at most about 130 mg, at most about 120 mg, at most about 110 mg, at most about 100 mg, at most about 95 mg, at most about 90 mg, at most about 85 mg, at most about 80 mg, at most about 75 mg, at most about 70 mg, at most about 65 mg, at most about 60 mg, at most about 55 mg, at most about 50 mg, at most about 45 mg, at most about 40 mg, at most about 35 mg, at most about 30 mg, at most about 25 mg, at most about 20 mg, at most about 15 mg, at most about 14 mg, at most about 13 mg, at most about 12 mg, at most about 11 mg, at most about 10 mg, at most about 9 mg, at most about 8 mg, at most about 7 mg, at most about 6 mg, at most about 5 mg, at most about 4 mg, at most about 3 mg, at most about 2 mg, at most about 1 mg, or less.

[0136] In some embodiments, progesterone or a progesterone derivative is provided in an amount of from about 1 mg to about 300 mg, about 1 mg to about 250 mg, about 1 mg to about 200 mg, about 1 mg to about 150 mg, about 1 mg to about 100 mg, about 1 mg to about 90 mg, about 1 mg to about 80 mg, about 1 mg to about 50 mg, about 1 mg to about 20 mg, about 1 mg to about 10 mg, about 5 mg to about 20 mg; about 20 mg to about 300 mg, about 20 mg to about250 mg, about 20 mg to about 200 mg, about 20 mg to about 150 mg, about 20 mg to about 100 mg, about 20 mg to about 90 mg, about 20 mg to about 80 mg, about 20 mg to about 50 mg, about 20 mg to about 40 mg, about 30 mg to about 40 mg, about 50 mg to about 300 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, about 50 mg to about 100 mg, about 50 mg to about 90 mg, about 50 mg to about 80 mg, about 60 mg to about 80 mg, or about 70 mg to about 80 mg.

[0137] In some embodiments, progesterone or a progesterone derivative is provided in an amount of at least about 1 mg / g, at least about 2 mg / g, at least about 3 mg / g, at least about 4 mg / g, at least about 5 mg / g, at least about 6 mg / g, at least about 7 mg / g, at least about 8 mg / g, at least about 9 mg / g, at least about 10 mg / g, at least about 11 mg / g, at least about 12 mg / g, at least about 13 mg / g, at least about 14 mg / g, at least about 15 mg / g, at least about 20 mg / g, at least about 25 mg / g, at least about 30 mg / g, at least about 35 mg / g, at least about 40 mg / g, at least about 45 mg / g, at least about 50 mg / g, at least about 55 mg / g, at least about 60 mg / g, at least about 65 mg / g, at least about 70 mg / g, at least about 75 mg / g, at least about 80 mg / g, at least about 85 mg / g, at least about 90 mg / g, at least about 95 mg / g, at least about 100 mg / g, at least about 110 mg / g, at least about 120 mg / g, at least about 130 mg / g, at least about 140 mg / g, at least about 150 mg / g, at least about 160 mg / g, at least about 170 mg / g, at least about 180 mg / g, at least about 190 mg / g, at least about 200 mg / g, at least about 210 mg / g, at least about 220 mg / g, at least about 230 mg / g, at least about 240 mg / g, at least about 250 mg / g, at least about 260 mg / g, at least about 270 mg / g, at least about 280 mg / g, at least about 290 mg / g, at least about 300 mg / g, at least about 310 mg / g, at least about 320 mg / g, at least about 330 mg / g, at least about 340 mg / g, at least about 350 mg / g, at least about 360 mg / g, at least about 370 mg / g, at least about 380 mg / g, at least about 390 mg / g, at least about 400 mg / g, at least about 410 mg / g, at least about 420 mg / g, at least about 430 mg / g, at least about 440 mg / g, at least about 450 mg / g, at least about 460 mg / g, at least about 470 mg / g, at least about 480 mg / g, at least about 490 mg / g, at least about 500 mg / g, at least about 510 mg / g, at least about 520 mg / g, at least about 530 mg / g, at least about 540 mg / g, at least about 550 mg / g, at least about 560 mg / g, at least about 570 mg / g, at least about 580 mg / g, at least about 590 mg / g, at least about 600 mg / g, at least about 610 mg / g, at least about 620 mg / g, at least about 630 mg / g, at least about 640 mg / g, at least about 650 mg / g, at least about 660 mg / g, at least about 670 mg / g, at least about 680 mg / g, at least about 690 mg / g, at least about 700 mg / g, at least about 710 mg / g, at least about 720 mg / g, at least about 730 mg / g, at least about 740 mg / g, at least about 750 mg / g, at least about 760 mg / g, at least about 770 mg / g, at least about 780 mg / g, at least about 790 mg / g, at least about 800 mg / g, at least about 810 mg / g, at leastabout 820 mg / g, at least about 830 mg / g, at least about 840 mg / g, at least about 850 mg / g, at least about 860 mg / g, at least about 870 mg / g, at least about 880 mg / g, at least about 890 mg / g, at least about 900 mg / g, at least about 910 mg / g, at least about 920 mg / g, at least about 930 mg / g, at least about 940 mg / g, at least about 950 mg / g, at least about 960 mg / g, at least about 970 mg / g, at least about 980 mg / g, at least about 990 mg / g, at least about 1,000 mg / g, at least about 1,050 mg / g, at least about 1,100 mg / g, at least about 1, 150 mg / g, at least about 1,200 mg / g, at least about 1,250 mg / g, at least about 1,300 mg / g, at least about 1,350 mg / g, at least about 1,400 mg / g, at least about 1,450 mg / g, at least about 1,500 mg / g, at least about 1,550 mg / g, at least about 1,600 mg / g, at least about 1,650 mg / g, at least about 1,700 mg / g, at least about 1,750 mg / g, at least about 1,800 mg / g, at least about 1,850 mg / g, at least about 1,900 mg / g, at least about 1,950 mg / g, at least about 2,000 mg / g, at least about 2,100 mg / g, at least about 2,200 mg / g, at least about 2,300 mg / g, at least about 2,400 mg / g, at least about 2,500 mg / g, at least about 2,600 mg / g, at least about 2,700 mg / g, at least about 2,800 mg / g, at least about 2,900 mg / g, at least about 3,000 mg / g, at least about 3,500 mg / g, at least about 4,000 mg / g, at least about 4,500 mg / g, at least about 5,000 mg / g, or more.

[0138] In some embodiments, progesterone or a progesterone derivative is provided in an amount of at most about 5,000 mg / g, at most about 4,500 mg / g, at most about 4,000 mg / g, at most about 3,500 mg / g, at most about 3,000 mg / g, at most about 2,900 mg / g, at most about 2,800 mg / g, at most about 2,700 mg / g, at most about 2,600 mg / g, at most about 2,500 mg / g, at most about 2,400 mg / g, at most about 2,300 mg / g, at most about 2,200 mg / g, at most about 2, 100 mg / g, at most about 2,000 mg / g, at most about 1,950 mg / g, at most about 1,900 mg / g, at most about 1,850 mg / g, at most about 1,800 mg / g, at most about 1,750 mg / g, at most about 1,700 mg / g, at most about 1,650 mg / g, at most about 1,600 mg / g, at most about 1,550 mg / g, at most about 1,500 mg / g, at most about 1,450 mg / g, at most about 1,400 mg / g, at most about 1,350 mg / g, at most about 1,300 mg / g, at most about 1,250 mg / g, at most about 1,200 mg / g, at most about 1,150 mg / g, at most about 1,100 mg / g, at most about 1,050 mg / g, at most about 1,000 mg / g, at most about 990 mg / g, at most about 980 mg / g, at most about 970 mg / g, at most about 960 mg / g, at most about 950 mg / g, at most about 940 mg / g, at most about 930 mg / g, at most about 920 mg / g, at most about 910 mg / g, at most about 900 mg / g, at most about 890 mg / g, at most about 880 mg / g, at most about 870 mg / g, at most about 860 mg / g, at most about 850 mg / g, at most about 840 mg / g, at most about 830 mg / g, at most about 820 mg / g, at most about 810 mg / g, at most about 800 mg / g, at most about 790 mg / g, at most about 780 mg / g, at most about 770 mg / g, at most about 760 mg / g, at most about 750 mg / g, at most about 740 mg / g, at most about 730 mg / g, at most about 720 mg / g, at most about 710 mg / g, at most about 700 mg / g,at most about 690 mg / g, at most about 680 mg / g, at most about 670 mg / g, at most about 660 mg / g, at most about 650 mg / g, at most about 640 mg / g, at most about 630 mg / g, at most about 620 mg / g, at most about 610 mg / g, at most about 600 mg / g, at most about 590 mg / g, at most about 580 mg / g, at most about 570 mg / g, at most about 560 mg / g, at most about 550 mg / g, at most about 540 mg / g, at most about 530 mg / g, at most about 520 mg / g, at most about 510 mg / g, at most about 500 mg / g, at most about 490 mg / g, at most about 480 mg / g, at most about 470 mg / g, at most about 460 mg / g, at most about 450 mg / g, at most about 440 mg / g, at most about 430 mg / g, at most about 420 mg / g, at most about 410 mg / g, at most about 400 mg / g, at most about 390 mg / g, at most about 380 mg / g, at most about 370 mg / g, at most about 360 mg / g, at most about 350 mg / g, at most about 340 mg / g, at most about 330 mg / g, at most about 320 mg / g, at most about 310 mg / g, at most about 300 mg / g, at most about 290 mg / g, at most about 280 mg / g, at most about 270 mg / g, at most about 260 mg / g, at most about 250 mg / g, at most about 240 mg / g, at most about 230 mg / g, at most about 220 mg / g, at most about 210 mg / g, at most about 200 mg / g, at most about 190 mg / g, at most about 180 mg / g, at most about 170 mg / g, at most about 160 mg / g, at most about 150 mg / g, at most about 140 mg / g, at most about 130 mg / g, at most about 120 mg / g, at most about 110 mg / g, at most about 100 mg / g, at most about 95 mg / g, at most about 90 mg / g, at most about 85 mg / g, at most about 80 mg / g, at most about 75 mg / g, at most about 70 mg / g, at most about 65 mg / g, at most about 60 mg / g, at most about 55 mg / g, at most about 50 mg / g, at most about 45 mg / g, at most about 40 mg / g, at most about 35 mg / g, at most about 30 mg / g, at most about 25 mg / g, at most about 20 mg / g, at most about 15 mg / g, at most about 14 mg / g, at most about 13 mg / g, at most about 12 mg / g, at most about 1 1 mg / g, at most about 10 mg / g, at most about 9 mg / g, at most about 8 mg / g, at most about 7 mg / g, at most about 6 mg / g, at most about 5 mg / g, at most about 4 mg / g, at most about 3 mg / g, at most about 2 mg / g, at most about 1 mg / g, or less.

[0139] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is provided in an amount of at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1. 1% w / v, at least about1 .2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1 .5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2. 1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4. 1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7.1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8.1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9. 1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 11% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0140] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is provided in an amount of at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5%w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0141] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is provided in an amount of at least about 0.001% weight by weight (wt / wt), at least about 0.002% wt / wt, at least about 0.003% wt / wt, at least about 0.004% wt / wt, at least about 0.005% wt / wt, at least about 0.006% wt / wt, at least about 0.007% wt / wt, at least about 0.008% wt / wt, at least about 0.009% wt / wt, at least about 0.01% wt / wt, at least about 0.02% wt / wt, at least about 0.03% wt / wt, at least about 0.04% wt / wt, at least about 0.05% wt / wt, at least about 0.06% wt / wt, at least about 0.07% wt / wt, at least about 0.08% wt / wt, at least about 0.09% wt / wt, at least about 0.1% wt / wt, at least about 0.19% wt / wt, at least about 0.2% wt / wt, at least about 0.3% wt / wt, at least about 0.4% wt / wt, at least about 0.5% wt / wt, at least about 0.6% wt / wt, at least about 0.7% wt / wt, at least about 0.8% wt / wt, at least about 0.9% wt / wt, at least about 1.0% wt / wt, at least about 1.1% wt / wt, at least about 1.2% wt / wt, at least about 1.3% wt / wt, at least about 1.4% wt / wt, at least about 1.5% wt / wt, at least about 1.6% wt / wt, at least about 1.697% wt / wt, at least about 1.7% wt / wt, at least about 1.8% wt / wt, at least about 1.9% wt / wt, at least about 2.0% wt / wt, at least about 2.1% wt / wt, at least about 2.2% wt / wt, at least about 2.3% wt / wt, at least about 2.4% wt / wt, at least about 2.5% wt / wt, at least about 2.6% wt / wt, at least about 2.7% wt / wt, at least about 2.8% wt / wt, at least about 2.9% wt / wt, at least about 3.0% wt / wt, at least about 3.1% wt / wt, at least about 3.2% wt / wt, at least about 3.3% wt / wt, at least about 3.4% wt / wt, at least about 3.5% wt / wt, at least about 3.6% wt / wt, at least about 3.7% wt / wt, at least about 3.8% wt / wt, at least about 3.9% wt / wt, at least about 4.0% wt / wt, at least about 4.1% wt / wt, at least about 4.2% wt / wt, at least about 4.3% wt / wt, at least about 4.4% wt / wt, at least about 4.5% wt / wt, at least about 4.6% wt / wt, at least about 4.7% wt / wt, at least about 4.8% wt / wt, at least about 4.9% wt / wt, at least about 5.0% wt / wt, at least about 5.1% wt / wt, at least about 5.2% wt / wt, at least about5.3% wt / wt, at least about 5.4% wt / wt, at least about 5.5% wt / wt, at least about 5.6% wt / wt, at least about 5.7% wt / wt, at least about 5.8% wt / wt, at least about 5.9% wt / wt, at least about 6.0% wt / wt, at least about 6.1% wt / wt, at least about 6.2% wt / wt, at least about 6.3% wt / wt, at least about 6.4% wt / wt, at least about 6.5% wt / wt, at least about 6.6% wt / wt, at least about 6.7% wt / wt, at least about 6.8% wt / wt, at least about 6.9% wt / wt, at least about 7.0% wt / wt, at least about 7.1% wt / wt, at least about 7.2% wt / wt, at least about 7.3% wt / wt, at least about 7.4% wt / wt, at least about 7.5% wt / wt, at least about 7.6% wt / wt, at least about 7.7% wt / wt, at least about 7.8% wt / wt, at least about 7.9% wt / wt, at least about 8.0% wt / wt, at least about 8.1% wt / wt, at least about 8.2% wt / wt, at least about 8.3% wt / wt, at least about 8.4% wt / wt, at least about 8.5% wt / wt, at least about 8.6% wt / wt, at least about 8.7% wt / wt, at least about 8.8% wt / wt, at least about 8.9% wt / wt, at least about 9.0% wt / wt, at least about 9.1% wt / wt, at least about 9.2% wt / wt, at least about 9.3% wt / wt, at least about 9.4% wt / wt, at least about 9.5% wt / wt, at least about 9.6% wt / wt, at least about 9.7% wt / wt, at least about 9.8% wt / wt, at least about 9.9% wt / wt, at least about 10% wt / wt, at least about 11% wt / wt, at least about 12% wt / wt, at least about 13% wt / wt, at least about 14% wt / wt, at least about 15% wt / wt, at least about 16% wt / wt, at least about 17% wt / wt, at least about 18% wt / wt, at least about 19% wt / wt, at least about 20% wt / wt, at least about 21% wt / wt, at least about 22% wt / wt, at least about 23% wt / wt, at least about 24% wt / wt, at least about 25% wt / wt, at least about 30% wt / wt, at least about 35% wt / wt, at least about 40% wt / wt, at least about 45% wt / wt, at least about 50% wt / wt, at least about 55% wt / wt, at least about 60% wt / wt, at least about 65% wt / wt, at least about 70% wt / wt, at least about 75% wt / wt, at least about 80% wt / wt, at least about 85% wt / wt, at least about 90% wt / wt, at least about 91% wt / wt, at least about 92% wt / wt, at least about 93% wt / wt, at least about 94% wt / wt, at least about 95% wt / wt, at least about 96% wt / wt, at least about 97% wt / wt, at least about 98% wt / wt, at least about 99% wt / wt, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0142] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is provided in an amount of at most about 99% wt / wt, at most about 98% wt / wt, at most about 97% wt / wt, at most about 96% wt / wt, at most about 95% wt / wt, at most about 94% wt / wt, at most about 93% wt / wt, at most about 92% wt / wt, at most about 91% wt / wt, at most about 90% wt / wt, at most about 85% wt / wt, at most about 80% wt / wt, at most about 75% wt / wt, at most about 70% wt / wt, at most about 65% wt / wt, at most about 60% wt / wt, at most about 55% wt / wt, at most about 50% wt / wt, at most about 45% wt / wt, at most about 40% wt / wt, at most about 35% wt / wt, at most about 30% wt / wt, at most about 25% wt / wt, at most about 24% wt / wt, at most about 23% wt / wt, at most about 22% wt / wt, atmost about 21% wt / wt, at most about 20% wt / wt, at most about 19% wt / wt, at most about 18% wt / wt, at most about 17% wt / wt, at most about 16% wt / wt, at most about 15% wt / wt, at most about 14% wt / wt, at most about 13% wt / wt, at most about 12% wt / wt, at most about 11% wt / wt, at most about 10% wt / wt, at most about 9.9% wt / wt, at most about 9.8% wt / wt, at most about 9.7% wt / wt, at most about 9.6% wt / wt, at most about 9.5% wt / wt, at most about 9.4% wt / wt, at most about 9.3% wt / wt, at most about 9.2% wt / wt, at most about 9.1% wt / wt, at most about 9.0% wt / wt, at most about 8.9% wt / wt, at most about 8.8% wt / wt, at most about 8.7% wt / wt, at most about 8.6% wt / wt, at most about 8.5% wt / wt, at most about 8.4% wt / wt, at most about 8.3% wt / wt, at most about 8.2% wt / wt, at most about 8.1% wt / wt, at most about 8.0% wt / wt, at most about 7.9% wt / wt, at most about 7.8% wt / wt, at most about 7.7% wt / wt, at most about 7.6% wt / wt, at most about 7.5% wt / wt, at most about 7.4% wt / wt, at most about 7.3% wt / wt, at most about 7.2% wt / wt, at most about 7.1% wt / wt, at most about 7.0% wt / wt, at most about 6.9% wt / wt, at most about 6.8% wt / wt, at most about 6.7% wt / wt, at most about 6.6% wt / wt, at most about 6.5% wt / wt, at most about 6.4% wt / wt, at most about 6.3% wt / wt, at most about 6.2% wt / wt, at most about 6.1% wt / wt, at most about 6.0% wt / wt, at most about 5.9% wt / wt, at most about 5.8% wt / wt, at most about 5.7% wt / wt, at most about 5.6% wt / wt, at most about 5.5% wt / wt, at most about 5.4% wt / wt, at most about 5.3% wt / wt, at most about 5.2% wt / wt, at most about 5.1% wt / wt, at most about 5.0% wt / wt, at most about 4.9% wt / wt, at most about 4.8% wt / wt, at most about 4.7% wt / wt, at most about 4.6% wt / wt, at most about 4.5% wt / wt, at most about 4.4% wt / wt, at most about 4.3% wt / wt, at most about 4.2% wt / wt, at most about 4.1% wt / wt, at most about 4.0% wt / wt, at most about 3.9% wt / wt, at most about 3.8% wt / wt, at most about 3.7% wt / wt, at most about 3.6% wt / wt, at most about 3.5% wt / wt, at most about 3.4% wt / wt, at most about 3.3% wt / wt, at most about 3.2% wt / wt, at most about 3.1% wt / wt, at most about 3.0% wt / wt, at most about 2.9% wt / wt, at most about 2.8% wt / wt, at most about 2.7% wt / wt, at most about 2.6% wt / wt, at most about 2.5% wt / wt, at most about 2.4% wt / wt, at most about 2.3% wt / wt, at most about 2.2% wt / wt, at most about 2.1% wt / wt, at most about 2.0% wt / wt, at most about 1 .9% wt / wt, at most about 1.8% wt / wt, at most about 1.7% wt / wt, at most about 1.697% wt / wt, at most about 1.6% wt / wt, at most about 1.5% wt / wt, at most about 1.4% wt / wt, at most about 1.3% wt / wt, at most about 1.2% wt / wt, at most about 1.1% wt / wt, at most about 1.0% wt / wt, at most about 0.9% wt / wt, at most about 0.8% wt / wt, at most about 0.7% wt / wt, at most about 0.6% wt / wt, at most about 0.5% wt / wt, at most about 0.4% wt / wt, at most about 0.3% wt / wt, at most about 0.2% wt / wt, at most about 0.19% wt / wt, at most about 0.1% wt / wt, at most about 0.09% wt / wt, at most about 0.08% wt / wt, at most about 0.07% wt / wt, at most about 0.06%wt / wt, at most about 0.05% wt / wt, at most about 0.04% wt / wt, at most about 0.03% wt / wt, at most about 0.02% wt / wt, at most about 0.01% wt / wt, at most about 0.009% wt / wt, at most about 0.008% wt / wt, at most about 0.007% wt / wt, at most about 0.006% wt / wt, at most about 0.005% wt / wt, at most about 0.004% wt / wt, at most about 0.003% wt / wt, at most about 0.002% wt / wt, at most about 0.001% wt / wt, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0143] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof is provided in an amount of from about 0.01% wt / wt to about 5% wt / wt, about 0.01% wt / wt to about 4.5% wt / wt, about 0.01% wt / wt to about 4% wt / wt, about 0.01% wt / wt to about 3.5% wt / wt, about 0.01% wt / wt to about 3% wt / wt, about 0.01% wt / wt to about 2.5% wt / wt, about 0.01% wt / wt to about 2% wt / wt, about 0.01% wt / wt to about 1.5% wt / wt, about 0.01% wt / wt to about 1% wt / wt, about 0.01% wt / wt to about 0.5% wt / wt, about 0.01% wt / wt to about 0.1% wt / wt, about 0.01% wt / wt to about 0.05% wt / wt, 0.1% wt / wt to about 5% wt / wt, about 0.1% wt / wt to about 4.5% wt / wt, about 0.1% wt / wt to about 4% wt / wt, about 0.1% wt / wt to about 3.5% wt / wt, about 0.1% wt / wt to about 3% wt / wt, about 0.1% wt / wt to about 2.5% wt / wt, about 0.1% wt / wt to about 2% wt / wt, about 0.1% wt / wt to about 1.5% wt / wt, about 0.1% wt / wt to about 1% wt / wt, about 0.1% wt / wt to about 0.5% wt / wt, about 0.5% wt / wt to about 5% wt / wt, about 0.5% wt / wt to about 4.5% wt / wt, about 0.5% wt / wt to about 4% wt / wt, 0.5% wt / wt to about 3.5% wt / wt, 0.5% wt / wt to about 3% wt / wt, 0.5% wt / wt to about 2.5% wt / wt, about 0.5% wt / wt to about 2% wt / wt, about 0.5% wt / wt to about 1.5% wt / wt, about 0.5% wt / wt to about 1% wt / wt, about 1% wt / wt to about 5% wt / wt, about 1% wt / wt to about 4.5% wt / wt, about 1% wt / wt to about 4% wt / wt, about 1% wt / wt to about 3.5% wt / wt, about 1% wt / wt to about 3% wt / wt, about 1% wt / wt to about 2.5% wt / wt, about 1% wt / wt to about 2% wt / wt, or about 1% wt / wt to about 1.5% wt / wt.

[0144] In some embodiments, progesterone, a progesterone derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in a gaseous dosage form. The gaseous dosage form can be useful for use inhalation by a subject.

[0145] In some embodiments, a pharmaceutical composition as disclosed herein can comprise a segesterone acetate, a segesterone acetate derivative, a pharmaceutically-acceptable salt thereof, or a combination thereof. In some embodiments, a pharmaceutical composition can comprise a therapeutically-effective amount of segesterone acetate or a segesterone acetate derivative.

[0146] In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically acceptable salt thereof as described herein can be administered in a dosageform. In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of at least about 1 milligram per milliliter (mg / mL), at least about 1.6 mg / mL, at least about 2 mg / mL, at least about 3 mg / mL, at least about 4 mg / mL, at least about 5 mg / mL, at least about 6 mg / mL, at least about 7 mg / mL, at least about 8 mg / mL, at least about 9 mg / mL, at least about 10 mg / mL, at least about 11 mg / mL, at least about 12 mg / mL, at least about 13 mg / mL, at least about 14 mg / mL, at least about 15 mg / mL, at least about 16 mg / mL, at least about 17 mg / mL, at least about 18 mg / mL, at least about 19 mg / mL, at least about 20 mg / mL, at least about 25 mg / mL, at least about 30 mg / mL, at least about 35 mg / mL, at least about 40 mg / mL, at least about 45 mg / mL, at least about 50 mg / mL, at least about 55 mg / mL, at least about 60 mg / mL, at least about 65 mg / mL, at least about 70 mg / mL, at least about 75 mg / mL, at least about 80 mg / mL, at least about 85 mg / mL, at least about 90 mg / mL, at least about 100 mg / mL, at least about 110 mg / mL, at least about 120 mg / mL, at least about 130 mg / mL, at least about 140 mg / mL, at least about 150 mg / mL, at least about 160 mg / mL, at least about 170 mg / mL, at least about 180 mg / mL, at least about 190 mg / mL, at least about 200 mg / mL, at least about 250 mg / mL, at least about 300 mg / mL, at least about 350 mg / mL, at least about 400 mg / mL, at least about 450 mg / mL, at least about 500 mg / mL, at least about 550 mg / mL, at least about 600 mg / mL, at least about 650 mg / mL, at least about 700 mg / mL, at least about 750 mg / mL, at least about 800 mg / mL, at least about 850 mg / mL, at least about 900 mg / mL, at least about 950 mg / mL, at least about 1,000 mg / mL, or more.

[0147] In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of at most about 1,000 mg / mL, at most about 950 mg / mL, at most about 900 mg / mL, at most about 850 mg / mL, at most about 800 mg / mL, at most about 750 mg / mL, at most about 700 mg / mL, at most about 650 mg / mL, at most about 600 mg / mL, at most about 550 mg / mL, at most about 500 mg / mL, at most about 450 mg / mL, at most about 400 mg / mL, at most about 350 mg / mL, at most about 300 mg / mL, at most about 250 mg / mL, at most about 200 mg / mL, at most about 190 mg / mL, at most about 180 mg / mL, at most about 170 mg / mL, at most about 160 mg / mL, at most about 150 mg / mL, at most about 140 mg / mL, at most about 130 mg / mL, at most about 120 mg / mL, at most about 110 mg / mL, at most about 100 mg / mL, at most about 95 mg / mL, at most about 90 mg / mL, at most about 85 mg / mL, at most about 80 mg / mL, at most about 75 mg / mL, at most about 70 mg / mL, at most about 65 mg / mL, at most about 60 mg / mL, at most about 55 mg / mL, at most about 50 mg / mL, at most about 45 mg / mL, at most about 40 mg / mL, at most about 35 mg / mL, at most about 30 mg / mL, at most about 25mg / mL, at most about 20 mg / mL, at most about 19 mg / mL, at most about 18 mg / mL, at most about 17 mg / mL, at most about 16 mg / mL, at most about 15 mg / mL, at most about 14 mg / mL, at most about 13 mg / mL, at most about 12 mg / mL, at most about 11 mg / mL, at most about 10 mg / mL, at most about 9 mg / mL, at most about 8 mg / mL, at most about 7 mg / mL, at most about 6 mg / mL, at most about 5 mg / mL, at most about 4 mg / mL, at most about 3 mg / mL, at most about 2 mg / mL, at most about 1 mg / mL or less.

[0148] In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically-acceptable salt thereof is present in a formulation in an amount of from about1 mg / mL to about 50 mg / mL, about 1 mg / mL to about 40 mg / mL, about 1 mg / mL to about 30 mg / mL, about 1 mg / mL to about 25 mg / mL, about 1 mg / mL to about 20 mg / mL, about 1 mg / mL to about 15 mg / mL, about 1 mg / mL to about 10 mg / mL, about 1 mg / mL to about 5 mg / mL, about 1 mg / mL to about 4 mg / mL, about 1 mg / mL to about 3 mg / mL, about 1 mg / mL to about 2 mg / mL, about 2 mg / mL to about 5 mg / mL, about 2 mg / mL to about 4 mg / mL, about2 mg / mL to about 3 mg / mL, about 3 mg / mL to about 5 mg / mL, about 4 mg / mL to about 5 mg / mL, about 5 mg / mL to about 50 mg / mL, about 5 mg / mL to about 40 mg / mL, about 5 mg / mL to about 30 mg / mL, about 5 mg / mL to about 25 mg / mL, about 5 mg / mL to about 20 mg / mL, about 5 mg / mL to about 15 mg / mL, about 5 mg / mL to about 10 mg / mL, about 10 mg / mL to about 50 mg / mL, about 10 mg / mL to about 40 mg / mL, about 10 mg / mL to about 30 mg / mL, about 10 mg / mL to about 25 mg / mL, about 10 mg / mL to about 20 mg / mL, about 10 mg / mL to about 15 mg / mL, about 15 mg / mL to about 50 mg / mL, about 15 mg / mL to about 40 mg / mL, about 15 mg / mL to about 30 mg / mL, about 15 mg / mL to about 25 mg / mL, about 15 mg / mL to about 20 mg / mL, about 20 mg / mL to about 50 mg / mL, about 20 mg / mL to about 40 mg / mL, about 20 mg / mL to about 30 mg / mL, about 20 mg / mL to about 25 mg / mL, about 25 mg / mL to about 50 mg / mL, about 25 mg / mL to about 40 mg / mL, about 25 mg / mL to about 30 mg / mL, about 30 mg / mL to about 50 mg / mL, about 30 mg / mL to about 40 mg / mL, or about 40 mg / mL to about 50 mg / mL.

[0149] In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in dosage form. In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of at least about 1 milligrams (mg), at least about 2 mg, at least about 3 mg, at least about 4 mg, at least about 4.1 mg, at least about 5 mg, at least about 5.8 mg, at least about 6 mg, at least about 7 mg, at least about 8 mg, at least about 8.2 mg, at least about 9 mg, at least about 10 mg, at least about 11 mg, at least about 12 mg, at least about 13 mg, at least about 14 mg, at least about 15 mg, at least about 20 mg, at least about 25 mg, at least about 30 mg, at least about 35 mg, atleast about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 110 mg, at least about 120 mg, at least about 130 mg, at least about 140 mg, at least about 150 mg, at least about 160 mg, at least about 170 mg, at least about 180 mg, at least about 190 mg, at least about 200 mg, at least about 210 mg, at least about 220 mg, at least about 230 mg, at least about 240 mg, at least about 250 mg, at least about 260 mg, at least about 270 mg, at least about 280 mg, at least about 290 mg, at least about 300 mg, at least about 310 mg, at least about 320 mg, at least about 330 mg, at least about 340 mg, at least about 350 mg, at least about 360 mg, at least about 370 mg, at least about 380 mg, at least about 390 mg, at least about 400 mg, at least about 410 mg, at least about 420 mg, at least about 430 mg, at least about 440 mg, at least about 450 mg, at least about 460 mg, at least about 470 mg, at least about 480 mg, at least about 490 mg, at least about 500 mg, at least about 510 mg, at least about 520 mg, at least about 530 mg, at least about 540 mg, at least about 550 mg, at least about 560 mg, at least about 570 mg, at least about 580 mg, at least about 590 mg, at least about 600 mg, at least about 610 mg, at least about 620 mg, at least about 630 mg, at least about 640 mg, at least about 650 mg, at least about 660 mg, at least about 670 mg, at least about 680 mg, at least about 690 mg, at least about 700 mg, at least about 710 mg, at least about 720 mg, at least about 730 mg, at least about 740 mg, at least about 750 mg, at least about 760 mg, at least about 770 mg, at least about 780 mg, at least about 790 mg, at least about 800 mg, at least about 810 mg, at least about 820 mg, at least about 830 mg, at least about 840 mg, at least about 850 mg, at least about 860 mg, at least about 870 mg, at least about 880 mg, at least about 890 mg, at least about 900 mg, at least about 910 mg, at least about 920 mg, at least about 930 mg, at least about 940 mg, at least about 950 mg, at least about 960 mg, at least about 970 mg, at least about 980 mg, at least about 990 mg, at least about 1,000 mg, at least about 1,050 mg, at least about 1,100 mg, at least about 1, 150 mg, at least about 1,200 mg, at least about 1,250 mg, at least about 1,300 mg, at least about 1,350 mg, at least about 1,400 mg, at least about 1,450 mg, at least about 1,500 mg, at least about 1,550 mg, at least about 1,600 mg, at least about 1,650 mg, at least about 1,700 mg, at least about 1,750 mg, at least about 1,800 mg, at least about 1,850 mg, at least about 1,900 mg, at least about 1,950 mg, at least about 2,000 mg, at least about 2,100 mg, at least about 2,200 mg, at least about 2,300 mg, at least about 2,400 mg, at least about 2,500 mg, at least about 2,600 mg, at least about 2,700 mg, at least about 2,800 mg, at least about 2,900 mg, at least about 3,000 mg, at least about 3,500 mg, at least about 4,000 mg, at least about 4,500 mg, at least about 5,000 mg, or more.

[0150] In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of at most about 5,000 mg, at most about 4,500 mg, at most about 4,000 mg, at most about 3,500 mg, at most about 3,000 mg, at most about 2,900 mg, at most about 2,800 mg, at most about 2,700 mg, at most about 2,600 mg, at most about 2,500 mg, at most about 2,400 mg, at most about 2,300 mg, at most about 2,200 mg, at most about 2,100 mg, at most about 2,000 mg, at most about 1,950 mg, at most about 1,900 mg, at most about 1,850 mg, at most about 1,800 mg, at most about 1,750 mg, at most about 1,700 mg, at most about 1,650 mg, at most about 1,600 mg, at most about 1,550 mg, at most about 1,500 mg, at most about 1,450 mg, at most about 1,400 mg, at most about 1,350 mg, at most about 1,300 mg, at most about 1,250 mg, at most about 1,200 mg, at most about 1,150 mg, at most about 1,100 mg, at most about 1,050 mg, at most about 1,000 mg, at most about 990 mg, at most about 980 mg, at most about 970 mg, at most about 960 mg, at most about 950 mg, at most about 940 mg, at most about 930 mg, at most about 920 mg, at most about 910 mg, at most about 900 mg, at most about 890 mg, at most about 880 mg, at most about 870 mg, at most about 860 mg, at most about 850 mg, at most about 840 mg, at most about 830 mg, at most about 820 mg, at most about 810 mg, at most about 800 mg, at most about 790 mg, at most about 780 mg, at most about 770 mg, at most about 760 mg, at most about 750 mg, at most about 740 mg, at most about 730 mg, at most about 720 mg, at most about 710 mg, at most about 700 mg, at most about 690 mg, at most about 680 mg, at most about 670 mg, at most about 660 mg, at most about 650 mg, at most about 640 mg, at most about 630 mg, at most about 620 mg, at most about 610 mg, at most about 600 mg, at most about 590 mg, at most about 580 mg, at most about 570 mg, at most about 560 mg, at most about 550 mg, at most about 540 mg, at most about 530 mg, at most about 520 mg, at most about 510 mg, at most about 500 mg, at most about 490 mg, at most about 480 mg, at most about 470 mg, at most about 460 mg, at most about 450 mg, at most about 440 mg, at most about 430 mg, at most about 420 mg, at most about 410 mg, at most about 400 mg, at most about 390 mg, at most about 380 mg, at most about 370 mg, at most about 360 mg, at most about 350 mg, at most about 340 mg, at most about 330 mg, at most about 320 mg, at most about 310 mg, at most about 300 mg, at most about 290 mg, at most about 280 mg, at most about 270 mg, at most about 260 mg, at most about 250 mg, at most about 240 mg, at most about 230 mg, at most about 220 mg, at most about 210 mg, at most about 200 mg, at most about 190 mg, at most about 180 mg, at most about 170 mg, at most about 160 mg, at most about 150 mg, at most about 140 mg, at most about 130 mg, at most about 120 mg, at most about 110 mg, at most about 100 mg, at most about 95 mg, at most about 90 mg, at most about 85 mg, at most about 80 mg, at mostabout 75 mg, at most about 70 mg, at most about 65 mg, at most about 60 mg, at most about 55 mg, at most about 50 mg, at most about 45 mg, at most about 40 mg, at most about 35 mg, at most about 30 mg, at most about 25 mg, at most about 20 mg, at most about 15 mg, at most about 14 mg, at most about 13 mg, at most about 12 mg, at most about 11 mg, at most about 10 mg, at most about 9 mg, at most about 8 mg, at most about 8.2 mg, at most about 7 mg, at most about 6 mg, at most about 5.8 mg, at most about 5 mg, at most about 4. 1 mg, at most about 4 mg, at most about 3 mg, at most about 2 mg, at most about 1 mg, or less.

[0151] In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of from about 1 mg to about 300 mg, about 1 mg to about 250 mg, about 1 mg to about 200 mg, about 1 mg to about 150 mg, about 1 mg to about 100 mg, about 1 mg to about 90 mg, about 1 mg to about 80 mg, about 1 mg to about 50 mg, about 1 mg to about 20 mg, about 1 mg to about 10 mg, about 20 mg to about 300 mg, about 20 mg to about 250 mg, about 20 mg to about 200 mg, about 20 mg to about 150 mg, about 20 mg to about 100 mg, about 20 mg to about 90 mg, about 20 mg to about 80 mg, about 20 mg to about 50 mg, about 20 mg to about 40 mg, about 30 mg to about 40 mg, about 50 mg to about 300 mg, about 50 mg to about 250 mg, about 50 mg to about 200 mg, about 50 mg to about 150 mg, about 50 mg to about 100 mg, about 50 mg to about 90 mg, about 50 mg to about 80 mg, about 60 mg to about 80 mg, or about 70 mg to about 80 mg.

[0152] In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of 8.2 mg. In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of 4.1 mg. In some embodiments, segesterone acetate or a segesterone acetate derivative is provided in an amount of 5.8 mg.

[0153] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at least about 1 mg / g at least about 2 mg / g, at least about 3 mg / g, at least about 4 mg / g, at least about 5 mg / g, at least about 6 mg / g, at least about 7 mg / g, at least about 8 mg / g, at least about 9 mg / g, at least about 10 mg / g, at least about 1 1 mg / g, at least about 12 mg / g, at least about 13 mg / g, at least about 14 mg / g, at least about 15 mg / g, at least about 20 mg / g, at least about 25 mg / g, at least about 30 mg / g, at least about 35 mg / g, at least about 40 mg / g, at least about 45 mg / g, at least about 50 mg / g, at least about 55 mg / g, at least about 60 mg / g, at least about 65 mg / g, at least about 70 mg / g, at least about 75 mg / g, at least about 80 mg / g, at least about 85 mg / g, at least about 90 mg / g, at least about 95 mg / g, at least about 100 mg / g, at least about 110 mg / g, at least about 120 mg / g, at least about 130 mg / g, at least about 140 mg / g, at least about 150 mg / g, at least about 160 mg / g, at least about 170 mg / g, at least about 180 mg / g, at least about 190 mg / g, at least about 200 mg / g, at least about 210 mg / g, atleast about 220 mg / g, at least about 230 mg / g, at least about 240 mg / g, at least about 250 mg / g, at least about 260 mg / g, at least about 270 mg / g, at least about 280 mg / g, at least about 290 mg / g, at least about 300 mg / g, at least about 310 mg / g, at least about 320 mg / g, at least about 330 mg / g, at least about 340 mg / g, at least about 350 mg / g, at least about 360 mg / g, at least about 370 mg / g, at least about 380 mg / g, at least about 390 mg / g, at least about 400 mg / g, at least about 410 mg / g, at least about 420 mg / g, at least about 430 mg / g, at least about 440 mg / g, at least about 450 mg / g, at least about 460 mg / g, at least about 470 mg / g, at least about 480 mg / g, at least about 490 mg / g, at least about 500 mg / g, at least about 510 mg / g, at least about 520 mg / g, at least about 530 mg / g, at least about 540 mg / g, at least about 550 mg / g, at least about 560 mg / g, at least about 570 mg / g, at least about 580 mg / g, at least about 590 mg / g, at least about 600 mg / g, at least about 610 mg / g, at least about 620 mg / g, at least about 630 mg / g, at least about 640 mg / g, at least about 650 mg / g, at least about 660 mg / g, at least about 670 mg / g, at least about 680 mg / g, at least about 690 mg / g, at least about 700 mg / g, at least about 710 mg / g, at least about 720 mg / g, at least about 730 mg / g, at least about 740 mg / g, at least about 750 mg / g, at least about 760 mg / g, at least about 770 mg / g, at least about 780 mg / g, at least about 790 mg / g, at least about 800 mg / g, at least about 810 mg / g, at least about 820 mg / g, at least about 830 mg / g, at least about 840 mg / g, at least about 850 mg / g, at least about 860 mg / g, at least about 870 mg / g, at least about 880 mg / g, at least about 890 mg / g, at least about 900 mg / g, at least about 910 mg / g, at least about 920 mg / g, at least about 930 mg / g, at least about 940 mg / g, at least about 950 mg / g, at least about 960 mg / g, at least about 970 mg / g, at least about 980 mg / g, at least about 990 mg / g, at least about 1,000 mg / g, at least about 1,050 mg / g, at least about 1,100 mg / g, at least about 1,150 mg / g, at least about 1,200 mg / g, at least about 1,250 mg / g, at least about 1,300 mg / g, at least about 1,350 mg / g, at least about 1,400 mg / g, at least about 1,450 mg / g, at least about 1,500 mg / g, at least about 1,550 mg / g, at least about 1,600 mg / g, at least about 1,650 mg / g, at least about 1,700 mg / g, at least about 1,750 mg / g, at least about 1,800 mg / g, at least about 1,850 mg / g, at least about 1,900 mg / g, at least about 1,950 mg / g, at least about 2,000 mg / g, at least about 2,100 mg / g, at least about 2,200 mg / g, at least about 2,300 mg / g, at least about 2,400 mg / g, at least about 2,500 mg / g, at least about 2,600 mg / g, at least about 2,700 mg / g, at least about 2,800 mg / g, at least about 2,900 mg / g, at least about 3,000 mg / g, at least about 3,500 mg / g, at least about 4,000 mg / g, at least about 4,500 mg / g, at least about 5,000 mg / g, or more.

[0154] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at most about 5,000 mg / g, at most about 4,500 mg / g, at most about 4,000 mg / g, at most about 3,500 mg / g, at most about 3,000 mg / g, at most about 2,900 mg / g, atmost about 2,800 mg / g, at most about 2,700 mg / g, at most about 2,600 mg / g, at most about 2,500 mg / g, at most about 2,400 mg / g, at most about 2,300 mg / g, at most about 2,200 mg / g, at most about 2,100 mg / g, at most about 2,000 mg / g, at most about 1,950 mg / g, at most about 1,900 mg / g, at most about 1,850 mg / g, at most about 1,800 mg / g, at most about 1,750 mg / g, at most about 1,700 mg / g, at most about 1,650 mg / g, at most about 1,600 mg / g, at most about 1,550 mg / g, at most about 1,500 mg / g, at most about 1,450 mg / g, at most about 1,400 mg / g, at most about 1,350 mg / g, at most about 1,300 mg / g, at most about 1,250 mg / g, at most about 1,200 mg / g, at most about 1,150 mg / g, at most about 1,100 mg / g, at most about 1,050 mg / g, at most about 1,000 mg / g, at most about 990 mg / g, at most about 980 mg / g, at most about 970 mg / g, at most about 960 mg / g, at most about 950 mg / g, at most about 940 mg / g, at most about 930 mg / g, at most about 920 mg / g, at most about 910 mg / g, at most about 900 mg / g, at most about 890 mg / g, at most about 880 mg / g, at most about 870 mg / g, at most about 860 mg / g, at most about 850 mg / g, at most about 840 mg / g, at most about 830 mg / g, at most about 820 mg / g, at most about 810 mg / g, at most about 800 mg / g, at most about 790 mg / g, at most about 780 mg / g, at most about 770 mg / g, at most about 760 mg / g, at most about 750 mg / g, at most about 740 mg / g, at most about 730 mg / g, at most about 720 mg / g, at most about 710 mg / g, at most about 700 mg / g, at most about 690 mg / g, at most about 680 mg / g, at most about 670 mg / g, at most about 660 mg / g, at most about 650 mg / g, at most about 640 mg / g, at most about 630 mg / g, at most about 620 mg / g, at most about 610 mg / g, at most about 600 mg / g, at most about 590 mg / g, at most about 580 mg / g, at most about 570 mg / g, at most about 560 mg / g, at most about 550 mg / g, at most about 540 mg / g, at most about 530 mg / g, at most about 520 mg / g, at most about 510 mg / g, at most about 500 mg / g, at most about 490 mg / g, at most about 480 mg / g, at most about 470 mg / g, at most about 460 mg / g, at most about 450 mg / g, at most about 440 mg / g, at most about 430 mg / g, at most about 420 mg / g, at most about 410 mg / g, at most about 400 mg / g, at most about 390 mg / g, at most about 380 mg / g, at most about 370 mg / g, at most about 360 mg / g, at most about 350 mg / g, at most about 340 mg / g, at most about 330 mg / g, at most about 320 mg / g, at most about 310 mg / g, at most about 300 mg / g, at most about 290 mg / g, at most about 280 mg / g, at most about 270 mg / g, at most about 260 mg / g, at most about 250 mg / g, at most about 240 mg / g, at most about 230 mg / g, at most about 220 mg / g, at most about 210 mg / g, at most about 200 mg / g, at most about 190 mg / g, at most about 180 mg / g, at most about 170 mg / g, at most about 160 mg / g, at most about 150 mg / g, at most about 140 mg / g, at most about 130 mg / g, at most about 120 mg / g, at most about 110 mg / g, at most about 100 mg / g, at most about 95 mg / g, at most about 90 mg / g, at most about 85 mg / g, at most about 80 mg / g, at most about 75 mg / g,at most about 70 mg / g, at most about 65 mg / g, at most about 60 mg / g, at most about 55 mg / g, at most about 50 mg / g, at most about 45 mg / g, at most about 40 mg / g, at most about 35 mg / g, at most about 30 mg / g, at most about 25 mg / g, at most about 20 mg / g, at most about 15 mg / g, at most about 14 mg / g, at most about 13 mg / g, at most about 12 mg / g, at most about 11 mg / g, at most about 10 mg / g, at most about 9 mg / g, at most about 8 mg / g, at most about 7 mg / g, at most about 6 mg / g, at most about 5 mg / g, at most about 4 mg / g, at most about 3 mg / g, at most about 2 mg / g, at most about 1 mg / g, or less.

[0155] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1 .3% w / v, at least about 1 .4% w / v, at least about 1 .5% w / v, at least about 1 .6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4.1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7.1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at leastabout 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8.1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9.1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 1 1% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of an active ingredient (e g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0156] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9. 1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v,at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1 .9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0157] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at least about 0.001% weight by weight (wt / wt), at least about0.002% wt / wt, at least about 0.003% wt / wt, at least about 0.004% wt / wt, at least about0.005% wt / wt, at least about 0.006% wt / wt, at least about 0.007% wt / wt, at least about0.008% wt / wt, at least about 0.009% wt / wt, at least about 0.01% wt / wt, at least about 0.02%wt / wt, at least about 0.03% wt / wt, at least about 0.04% wt / wt, at least about 0.05% wt / wt, at least about 0.06% wt / wt, at least about 0.07% wt / wt, at least about 0.08% wt / wt, at least about 0.09% wt / wt, at least about 0.1% wt / wt, at least about 0.19% wt / wt, at least about 0.2% wt / wt, at least about 0.3% wt / wt, at least about 0.4% wt / wt, at least about 0.5% wt / wt, at least about 0.6% wt / wt, at least about 0.7% wt / wt, at least about 0.8% wt / wt, at least about 0.9% wt / wt, at least about 1.0% wt / wt, at least about 1.1% wt / wt, at least about 1.2% wt / wt, at least about 1.3% wt / wt, at least about 1.4% wt / wt, at least about 1.5% wt / wt, at least about 1.6% wt / wt, at least about 1.697% wt / wt, at least about 1.7% wt / wt, at least about 1.8% wt / wt, at least about 1.9% wt / wt, at least about 2.0% wt / wt, at least about 2.1% wt / wt, at least about 2.2% wt / wt, at least about 2.3% wt / wt, at least about 2.4% wt / wt, at least about 2.5% wt / wt, at least about 2.6% wt / wt, at least about 2.7% wt / wt, at least about 2.8% wt / wt, at least about 2.9% wt / wt, at least about 3.0% wt / wt, at least about 3.1% wt / wt, at least about 3.2% wt / wt, at least about 3.3% wt / wt, at least about 3.4% wt / wt, at least about 3.5% wt / wt, at least about 3.6% wt / wt, at least about 3.7% wt / wt, at least about 3.8% wt / wt, at least about 3.9% wt / wt, at least about 4.0% wt / wt, at least about 4.1% wt / wt, at least about 4.2% wt / wt, at least about 4.3% wt / wt, at least about 4.4% wt / wt, at least about 4.5% wt / wt, at least about 4.6% wt / wt, at least about 4.7% wt / wt, at least about 4.8% wt / wt, at least about 4.9% wt / wt, at least about 5.0% wt / wt, at least about 5.1% wt / wt, at least about 5.2% wt / wt, at least about 5.3% wt / wt, at least about 5.4% wt / wt, at least about 5.5% wt / wt, at least about 5.6% wt / wt, at least about 5.7% wt / wt, at least about 5.8% wt / wt, at least about 5.9% wt / wt, at least about 6.0% wt / wt, at least about 6.1% wt / wt, at least about 6.2% wt / wt, at least about 6.3% wt / wt, at least about 6.4% wt / wt, at least about 6.5% wt / wt, at least about 6.6% wt / wt, at least about 6.7% wt / wt, at least about 6.8% wt / wt, at least about 6.9% wt / wt, at least about 7.0% wt / wt, at least about 7.1% wt / wt, at least about 7.2% wt / wt, at least about 7.3% wt / wt, at least about 7.4% wt / wt, at least about 7.5% wt / wt, at least about 7.6% wt / wt, at least about 7.7% wt / wt, at least about 7.8% wt / wt, at least about 7.9% wt / wt, at least about 8.0% wt / wt, at least about 8.1% wt / wt, at least about 8.2% wt / wt, at least about 8.3% wt / wt, at least about 8.4% wt / wt, at least about 8.5% wt / wt, at least about 8.6% wt / wt, at least about 8.7% wt / wt, at least about 8.8% wt / wt, at least about 8.9% wt / wt, at least about 9.0% wt / wt, at least about 9.1% wt / wt, at least about 9.2% wt / wt, at least about 9.3% wt / wt, at least about 9.4% wt / wt, at least about 9.5% wt / wt, at least about 9.6% wt / wt, at least about 9.7% wt / wt, at least about 9.8% wt / wt, at least about 9.9% wt / wt, at least about 10% wt / wt, at least about 11% wt / wt, at least about 12% wt / wt, at least about 13% wt / wt, at least about 14% wt / wt, at least about 15% wt / wt, at least about 16% wt / wt, at least about 17% wt / wt, at least about 18% wt / wt, at least about 19% wt / wt, at leastabout 20% wt / wt, at least about 21% wt / wt, at least about 22% wt / wt, at least about 23% wt / wt, at least about 24% wt / wt, at least about 25% wt / wt, at least about 30% wt / wt, at least about 35% wt / wt, at least about 40% wt / wt, at least about 45% wt / wt, at least about 50% wt / wt, at least about 55% wt / wt, at least about 60% wt / wt, at least about 65% wt / wt, at least about 70% wt / wt, at least about 75% wt / wt, at least about 80% wt / wt, at least about 85% wt / wt, at least about 90% wt / wt, at least about 91% wt / wt, at least about 92% wt / wt, at least about 93% wt / wt, at least about 94% wt / wt, at least about 95% wt / wt, at least about 96% wt / wt, at least about 97% wt / wt, at least about 98% wt / wt, at least about 99% wt / wt, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0158] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of at most about 99% wt / wt, at most about 98% wt / wt, at most about 97% wt / wt, at most about 96% wt / wt, at most about 95% wt / wt, at most about 94% wt / wt, at most about 93% wt / wt, at most about 92% wt / wt, at most about 91% wt / wt, at most about 90% wt / wt, at most about 85% wt / wt, at most about 80% wt / wt, at most about 75% wt / wt, at most about 70% wt / wt, at most about 65% wt / wt, at most about 60% wt / wt, at most about 55% wt / wt, at most about 50% wt / wt, at most about 45% wt / wt, at most about 40% wt / wt, at most about 35% wt / wt, at most about 30% wt / wt, at most about 25% wt / wt, at most about 24% wt / wt, at most about 23% wt / wt, at most about 22% wt / wt, at most about 21% wt / wt, at most about 20% wt / wt, at most about 19% wt / wt, at most about 18% wt / wt, at most about 17% wt / wt, at most about 16% wt / wt, at most about 15% wt / wt, at most about 14% wt / wt, at most about 13% wt / wt, at most about 12% wt / wt, at most about 11% wt / wt, at most about 10% wt / wt, at most about 9.9% wt / wt, at most about 9.8% wt / wt, at most about 9.7% wt / wt, at most about 9.6% wt / wt, at most about 9.5% wt / wt, at most about 9.4% wt / wt, at most about 9.3% wt / wt, at most about 9.2% wt / wt, at most about 9.1% wt / wt, at most about 9.0% wt / wt, at most about 8.9% wt / wt, at most about 8.8% wt / wt, at most about 8.7% wt / wt, at most about 8.6% wt / wt, at most about 8.5% wt / wt, at most about 8.4% wt / wt, at most about 8.3% wt / wt, at most about 8.2% wt / wt, at most about 8.1% wt / wt, at most about 8.0% wt / wt, at most about 7.9% wt / wt, at most about 7.8% wt / wt, at most about 7.7% wt / wt, at most about 7.6% wt / wt, at most about 7.5% wt / wt, at most about 7.4% wt / wt, at most about 7.3% wt / wt, at most about 7.2% wt / wt, at most about 7.1% wt / wt, at most about 7.0% wt / wt, at most about 6.9% wt / wt, at most about 6.8% wt / wt, at most about 6.7% wt / wt, at most about 6.6% wt / wt, at most about 6.5% wt / wt, at most about 6.4% wt / wt, at most about 6.3% wt / wt, at most about 6.2% wt / wt, at most about 6.1% wt / wt, at most about 6.0% wt / wt, at most about 5.9% wt / wt, at most about 5.8% wt / wt, at most about 5.7% wt / wt, at most about 5.6% wt / wt, at most about 5.5% wt / wt, at mostabout 5.4% wt / wt, at most about 5.3% wt / wt, at most about 5.2% wt / wt, at most about 5.1% wt / wt, at most about 5.0% wt / wt, at most about 4.9% wt / wt, at most about 4.8% wt / wt, at most about 4.7% wt / wt, at most about 4.6% wt / wt, at most about 4.5% wt / wt, at most about 4.4% wt / wt, at most about 4.3% wt / wt, at most about 4.2% wt / wt, at most about 4.1% wt / wt, at most about 4.0% wt / wt, at most about 3.9% wt / wt, at most about 3.8% wt / wt, at most about 3.7% wt / wt, at most about 3.6% wt / wt, at most about 3.5% wt / wt, at most about 3.4% wt / wt, at most about 3.3% wt / wt, at most about 3.2% wt / wt, at most about 3.1% wt / wt, at most about 3.0% wt / wt, at most about 2.9% wt / wt, at most about 2.8% wt / wt, at most about 2.7% wt / wt, at most about 2.6% wt / wt, at most about 2.5% wt / wt, at most about 2.4% wt / wt, at most about 2.3% wt / wt, at most about 2.2% wt / wt, at most about 2.1% wt / wt, at most about 2.0% wt / wt, at most about 1.9% wt / wt, at most about 1.8% wt / wt, at most about 1.7% wt / wt, at most about 1.697% wt / wt, at most about 1.6% wt / wt, at most about 1.5% wt / wt, at most about 1.4% wt / wt, at most about 1.3% wt / wt, at most about 1.2% wt / wt, at most about 1.1% wt / wt, at most about 1.0% wt / wt, at most about 0.9% wt / wt, at most about 0.8% wt / wt, at most about 0.7% wt / wt, at most about 0.6% wt / wt, at most about 0.5% wt / wt, at most about 0.4% wt / wt, at most about 0.3% wt / wt, at most about 0.2% wt / wt, at most about 0.19% wt / wt, at most about 0.1% wt / wt, at most about 0.09% wt / wt, at most about 0.08% wt / wt, at most about 0.07% wt / wt, at most about 0.06% wt / wt, at most about 0.05% wt / wt, at most about 0.04% wt / wt, at most about 0.03% wt / wt, at most about 0.02% wt / wt, at most about 0.01% wt / wt, at most about 0.009% wt / wt, at most about 0.008% wt / wt, at most about 0.007% wt / wt, at most about 0.006% wt / wt, at most about 0.005% wt / wt, at most about 0.004% wt / wt, at most about 0.003% wt / wt, at most about 0.002% wt / wt, at most about 0.001% wt / wt, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0159] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of from about 0.01% wt / wt to about 5% wt / wt, about 0.01% wt / wt to about 4.5% wt / wt, about 0.01% wt / wt to about 4% wt / wt, about 0.01% wt / wt to about 3.5% wt / wt, about 0.01% wt / wt to about 3% wt / wt, about 0.01% wt / wt to about 2.5% wt / wt, about 0.01% wt / wt to about 2% wt / wt, about 0.01% wt / wt to about 1.5% wt / wt, about 0.01% wt / wt to about 1% wt / wt, about 0.01% wt / wt to about 0.5% wt / wt, about 0.01% wt / wt to about 0.1% wt / wt, about 0.01% wt / wt to about 0.05% wt / wt, 0.1% wt / wt to about 5% wt / wt, about 0.1% wt / wt to about 4.5% wt / wt, about 0.1% wt / wt to about 4% wt / wt, about 0.1% wt / wt to about 3.5% wt / wt, about 0.1% wt / wt to about 3% wt / wt, about 0.1% wt / wt to about 2.5% wt / wt, about 0.1% wt / wt to about 2% wt / wt, about 0.1% wt / wt to about 1.5% wt / wt, about 0.1% wt / wtto about 1% wt / wt, about 0.1% wt / wt to about 0.5% wt / wt, about 0.5% wt / wt to about 5% wt / wt, about 0.5% wt / wt to about 4.5% wt / wt, about 0.5% wt / wt to about 4% wt / wt, 0.5% wt / wt to about 3.5% wt / wt, 0.5% wt / wt to about 3% wt / wt, 0.5% wt / wt to about 2.5% wt / wt, about 0.5% wt / wt to about 2% wt / wt, about 0.5% wt / wt to about 1.5% wt / wt, about 0.5% wt / wt to about 1% wt / wt, about 1% wt / wt to about 5% wt / wt, about 1% wt / wt to about 4.5% wt / wt, about 1% wt / wt to about 4% wt / wt, about 1% wt / wt to about 3.5% wt / wt, about 1% wt / wt to about 3% wt / wt, about 1% wt / wt to about 2.5% wt / wt, about 1% wt / wt to about 2% wt / wt, or about 1% wt / wt to about 1.5% wt / wt.

[0160] In some embodiments, segesterone acetate, a segesterone acetate derivative is provided in an amount of 0.1% wt / wt. In some embodiments, testosterone or a testosterone derivative is provided in an amount of 0.19% wt / wt. In some embodiments, testosterone or a testosterone derivative is provided in an amount of 0.2% wt / wt.

[0161] In some embodiments, segesterone acetate, a segesterone acetate derivative, or a pharmaceutically-acceptable salt thereof as described herein can be administered in a gaseous dosage form. The gaseous dosage form can be useful for use inhalation by a subject.

[0162] In some embodiments, a pharmaceutical composition can be administered as separate formulations (e.g., a first formulation and a second formulation). For example, a pharmaceutical composition can be administered as a first formulation comprising a therapeutically-effective amount of testosterone and a second formulation comprising a therapeutically-effective amount of segesterone acetate. Alternatively, in some embodiments, a pharmaceutical composition can be administered as a single formulation. For example, a pharmaceutical composition can be administered as a single formulation comprising a therapeutically-effective amount of testosterone and a therapeutically-effective amount of segesterone acetate.

[0163] A formulation as disclosed herein can comprise testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof and progesterone, a derivative thereof, or a pharmaceutically acceptable salt thereof in a ratio of 1 : 1. For example, a formulation comprising about 10 mg of testosterone and about 10 mg of progesterone. In another embodiment, the ratio can be based on the molecular weight or moles of a first therapeutic compound (e.g., testosterone) as compared to the molecular weight or moles of a second therapeutic compound (e g., progesterone). Additional non-limiting ratios of a first therapeutic compound to a second therapeutic compound can be about l.Fabout 1, about 1.2:about 1, about 1.3:about 1, about 1.4:about 1, about 1.5:about 1, about 1.6:about 1, about 1.7:about 1, about 1.8:about 1, about 1.9:about 1, about 2:about 1, about 3:about 1, about 4:about 1, about 5:about 1, about 6:about 1,about 7:about 1, about 8:about 1, about 9:about 1, about 10:about 1, about l l:about 1, about 12:about 1, about 13:about 1, about 14:about 1, about 15:about 1, about 16:about 1, about 17:about 1, about 18:about 1, about 19:about 1, or about 20: about 1.

[0164] In some embodiments, a pharmaceutical composition can be administered as a single formulation of testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof and progesterone, a derivative thereof, or a pharmaceutically acceptable salt thereof.

[0165] In some embodiments, a pharmaceutical composition can be administered as a single formulation of testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof and segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof.

[0166] In some embodiments, a pharmaceutical composition can be administered as a single formulation of testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof; progesterone, a derivative thereof, or a pharmaceutically acceptable salt thereof; and a third active ingredient (e.g., an additional hormone, a therapeutic agent for the treatment of an STD / STI).

[0167] In some embodiments, a third active ingredient as described herein can be administered in an amount of at least about 1 milligrams (mg), at least about 5 mg, at least about 10 mg, at least about 15 mg, at least about 20 mg, at least about 25 mg, at least about 30 mg, at least about 35 mg, at least about 40 mg, at least about 45 mg, at least about 50 mg, at least about 55 mg, at least about 60 mg, at least about 65 mg, at least about 70 mg, at least about 75 mg, at least about 80 mg, at least about 85 mg, at least about 90 mg, at least about 95 mg, at least about 100 mg, at least about 110 mg, at least about 120 mg, at least about 130 mg, at least about 140 mg, at least about 150 mg, at least about 160 mg, at least about 170 mg, at least about 180 mg, at least about 190 mg, at least about 200 mg, at least about 210 mg, at least about 220 mg, at least about 230 mg, at least about 240 mg, at least about 250 mg, at least about 260 mg, at least about 270 mg, at least about 280 mg, at least about 290 mg, at least about 300 mg, at least about 310 mg, at least about 320 mg, at least about 330 mg, at least about 340 mg, at least about 350 mg, at least about 360 mg, at least about 370 mg, at least about 380 mg, at least about 390 mg, at least about 400 mg, at least about 410 mg, at least about 420 mg, at least about 430 mg, at least about 440 mg, at least about 450 mg, at least about 460 mg, at least about 470 mg, at least about 480 mg, at least about 490 mg, at least about 500 mg, at least about 510 mg, at least about 520 mg, at least about 530 mg, at least about 540 mg, at least about 550 mg, at least about 560 mg, at least about 570 mg, at least about 580 mg, at least about 590 mg, at least about 600 mg, at least about 610 mg, at least about 620 mg, at least about 630 mg, at least about 640 mg, at least about 650mg, at least about 660 mg, at least about 670 mg, at least about 680 mg, at least about 690 mg, at least about 700 mg, at least about 710 mg, at least about 720 mg, at least about 730 mg, at least about 740 mg, at least about 750 mg, at least about 760 mg, at least about 770 mg, at least about 780 mg, at least about 790 mg, at least about 800 mg, at least about 810 mg, at least about 820 mg, at least about 830 mg, at least about 840 mg, at least about 850 mg, at least about 860 mg, at least about 870 mg, at least about 880 mg, at least about 890 mg, at least about 900 mg, at least about 910 mg, at least about 920 mg, at least about 930 mg, at least about 940 mg, at least about 950 mg, at least about 960 mg, at least about 970 mg, at least about 980 mg, at least about 990 mg, at least about 1,000 mg, at least about 1,050 mg, at least about 1,100 mg, at least about 1,150 mg, at least about 1,200 mg, at least about 1,250 mg, at least about 1,300 mg, at least about 1,350 mg, at least about 1,400 mg, at least about 1,450 mg, at least about 1,500 mg, at least about 1,550 mg, at least about 1,600 mg, at least about 1,650 mg, at least about 1,700 mg, at least about1,750 mg, at least about 1,800 mg, at least about 1,850 mg, at least about 1,900 mg, at least about 1,950 mg, at least about 2,000 mg, at least about 2,100 mg, at least about 2,200 mg, at least about 2,300 mg, at least about 2,400 mg, at least about 2,500 mg, at least about 2,600 mg, at least about 2,700 mg, at least about 2,800 mg, at least about 2,900 mg, at least about 3,000 mg, at least about 3,500 mg, at least about 4,000 mg, at least about 4,500 mg, at least about 5,000 mg, or more.

[0168] In some embodiments, a third active ingredient as described herein can be administered in an amount of at most about 5,000 mg, at most about 4,500 mg, at most about 4,000 mg, at most about 3,500 mg, at most about 3,000 mg, at most about 2,900 mg, at most about 2,800 mg, at most about 2,700 mg, at most about 2,600 mg, at most about 2,500 mg, at most about 2,400 mg, at most about 2,300 mg, at most about 2,200 mg, at most about 2,100 mg, at most about 2,000 mg, at most about 1,950 mg, at most about 1,900 mg, at most about 1,850 mg, at most about 1,800 mg, at most about 1,750 mg, at most about 1,700 mg, at most about 1,650 mg, at most about 1,600 mg, at most about 1,550 mg, at most about 1,500 mg, at most about 1,450 mg, at most about 1,400 mg, at most about 1,350 mg, at most about 1,300 mg, at most about 1,250 mg, at most about 1,200 mg, at most about 1,150 mg, at most about 1,100 mg, at most about 1,050 mg, at most about 1,000 mg, at most about 990 mg, at most about 980 mg, at most about 970 mg, at most about 960 mg, at most about 950 mg, at most about 940 mg, at most about 930 mg, at most about 920 mg, at most about 910 mg, at most about 900 mg, at most about 890 mg, at most about 880 mg, at most about 870 mg, at most about 860 mg, at most about 850 mg, at most about 840 mg, at most about 830 mg, at most about 820 mg, at most about 810 mg, at most about 800 mg, at most about 790 mg, at most about 780 mg, at mostabout 770 mg, at most about 760 mg, at most about 750 mg, at most about 740 mg, at most about 730 mg, at most about 720 mg, at most about 710 mg, at most about 700 mg, at most about 690 mg, at most about 680 mg, at most about 670 mg, at most about 660 mg, at most about 650 mg, at most about 640 mg, at most about 630 mg, at most about 620 mg, at most about 610 mg, at most about 600 mg, at most about 590 mg, at most about 580 mg, at most about 570 mg, at most about 560 mg, at most about 550 mg, at most about 540 mg, at most about 530 mg, at most about 520 mg, at most about 510 mg, at most about 500 mg, at most about 490 mg, at most about 480 mg, at most about 470 mg, at most about 460 mg, at most about 450 mg, at most about 440 mg, at most about 430 mg, at most about 420 mg, at most about 410 mg, at most about 400 mg, at most about 390 mg, at most about 380 mg, at most about 370 mg, at most about 360 mg, at most about 350 mg, at most about 340 mg, at most about 330 mg, at most about 320 mg, at most about 310 mg, at most about 300 mg, at most about 290 mg, at most about 280 mg, at most about 270 mg, at most about 260 mg, at most about 250 mg, at most about 240 mg, at most about 230 mg, at most about 220 mg, at most about 210 mg, at most about 200 mg, at most about 190 mg, at most about 180 mg, at most about 170 mg, at most about 160 mg, at most about 150 mg, at most about 140 mg, at most about 130 mg, at most about 120 mg, at most about 110 mg, at most about 100 mg, at most about 95 mg, at most about 90 mg, at most about 85 mg, at most about 80 mg, at most about 75 mg, at most about 70 mg, at most about 65 mg, at most about 60 mg, at most about 55 mg, at most about 50 mg, at most about 45 mg, at most about 40 mg, at most about 35 mg, at most about 30 mg, at most about 25 mg, at most about 20 mg, at most about 15 mg, at most about 10 mg, at most about 9 mg, at most about 8 mg, at most about 7 mg, at most about 6 mg, at most about 5 mg, at most about 4 mg, at most about 3 mg, at most about 2 mg, at most about 1 mg, or less.

[0169] A composition as described herein can comprise at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1.5% w / v, at least about 1.6%w / v, at least about 1 .7% w / v, at least about 1.8% w / v, at least about 1 .9% w / v, at least about 2.0% w / v, at least about 2. 1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4. 1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7.1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8.1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9. 1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 11% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0170] A composition as described herein can comprise at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, atmost about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of an active ingredient (e.g., a first active ingredient, a second active ingredient, a third active ingredient, etc.).

[0171] Depending on the intended mode of administration, the pharmaceutical compositions as described herein can be in the form of solid, semi-solid, gaseous, or liquid dosage forms. In some embodiments, a solid dosage form can be, for example, a tablet (e.g., a chewable tablet), a suppository, a suppository troche, a pill, a capsule, a powder, a dispersible powder, a granule, a gum, a patch, a dentifrice, a gel tab, an emulsion in a hard or soft gel capsule, a feed, a food, a pellet, a lozenge, a nanoparticle, or any combination thereof. In some embodiments, a liquid dosage form can be, for example, a liquid, a suspension, a liquid suspension, a nanosuspension, an aqueous suspension, an oily suspension, an elixir, an emulsion, a syrup, a lotion, a cream, a drop, an ointment, an emulsion, a gel (e.g., microgel), or any combination thereof. In some embodiments, a gaseous dosage form can be, for example, a gas, an aerosol, an inhalant, a spray, or any combination thereof. In some embodiments, the dosage form can be a combination of a solid and a liquid dosage form (e.g., a patch containing a gel). In some embodiments, pharmaceutical formulations described herein are administrable to a subject in a variety of ways by multiple administration routes, including but not limited to, oral, parenteral (e.g., intravenous, subcutaneous, intramuscular, intramedullary injections, intrathecal, direct intraventricular, intraperitoneal, intralymphatic, intranasal injections), intranasal, buccal, topical or transderm al administration routes. The pharmaceutical formulations described herein include, but are not limited to, aqueous liquid dispersions, self-emulsifying dispersions, solid solutions, liposomal dispersions, aerosols, solid dosage forms, powders, immediate release formulations, controlled release formulations, fast melt formulations, tablets, dissolvable sheets, capsules, pills, delayed release formulations, extended release formulations, pulsatile release formulations, multiparticulate formulations, and mixed immediate and controlled release formulations.

[0172] In some embodiments, the pharmaceutical composition disclosed herein is formulated into solutions, suspensions, lotions, gels, pastes, shampoos, scrubs, rubs, smears, medicated sticks, medicated bandages, balms, creams or ointments. In one aspect, the compounds disclosed herein are administered topically to the skin. In another aspect, the compounds disclosed herein are administered directly into a body cavity using non- degradable or degradable delivery systems. In another aspect, the compounds disclosed herein are administered directly to the reproductive tract of men or women using non- degradable or degradable delivery systems. In some embodiments, the compounds disclosed herein are administered non-topically. In some embodiments, the non-topical composition is formulated into a solution, liquid suspension, a lotion, a gel, a paste, a shampoo, a scrub, a rub, a smear, a medicated stick, a medicated bandage or a cream. In some embodiments, the non-topical composition is formulated as an injectable composition, an oral composition, an inhalable composition or a sublingual composition. In some embodiments, the composition is formulated as an injectable composition.

[0173] In another aspect, the pharmaceutical composition disclosed herein are formulated for intranasal administration. Such formulations include nasal sprays, nasal mists, gels / depots, and the like.

[0174] In another aspect, the pharmaceutical composition disclosed herein are formulated as eye drops.

[0175] In any of the aforementioned aspects are further embodiments in which the effective amount of the pharmaceutical composition disclosed herein is: (a) systemically administered to the mammal; and / or (b) administered orally to the mammal; and / or (c) intravenously administered to the mammal; and / or (d) administered by inhalation to the mammal; and / or (e) administered by nasal administration to the mammal; or and / or (f) administered by injection to the mammal; and / or (g) administered topically to the mammal; and / or (h) administered by ophthalmic administration; and / or (i) administered rectally to the mammal; and / or (j) administered non-systemically or locally to the mammal.

[0176] In some embodiments, a pharmaceutical composition as described herein is in a unit dosage form suitable for single administration of a precise dosage. Multiple therapeutic agents can be administered in any order or simultaneously. If simultaneously, the multiple therapeutic agents can be provided in a single, unified form, or in multiple forms, for example, as multiple separate pills or injections. The compounds can be packed together or separately, in a single package or in a plurality of packages. One or all of the therapeutic agents can be given in multiple doses. If not simultaneous, the timing between the multiple doses can vary.

[0177] In certain embodiments, the pharmaceutical composition as described herein is administered in a local rather than systemic manner.

[0178] In some embodiments, a pharmaceutical composition as described herein is administered topically. In some embodiments, a pharmaceutical composition as described herein is administered systemically.

[0179] In some embodiments, a pharmaceutical composition as described herein is in the form of a tablet. In other embodiments, a pharmaceutical composition as described herein are in the form of a capsule. In other embodiments, a pharmaceutical composition as described herein are in the form of a dissolvable sheet.

[0180] In one aspect, liquid formulation dosage forms for oral administration are in the form of aqueous suspensions or solutions selected from the group including, but not limited to, aqueous oral dispersions, emulsions, solutions, elixirs, gels, and syrups.

[0181] For administration by inhalation, a pharmaceutical composition as described herein is formulated for use as an aerosol, a mist or a powder.

[0182] For buccal or sublingual administration, a composition as described herein may take the form of tablets, dissolvable sheets, lozenges, or gels formulated in a conventional manner.

[0183] In some embodiments, a pharmaceutical composition as described herein are prepared as transdermal dosage forms (for examples of compositions prepared as transdermal and topical formulations, see e g., U.S. Patent App. 20050020552A1 or PCT App. No. W02003028667A2).

[0184] In one aspect, a pharmaceutical composition as described herein is formulated into a pharmaceutical composition suitable for intramuscular, subcutaneous, or intravenous injection.

[0185] In some embodiments, a pharmaceutical composition as described herein disclosed herein is be administered topically and can be formulated into a variety of topically administrable compositions, such as solutions, suspensions, lotions, gels, pastes, medicated sticks, balms, creams or ointments.

[0186] In some embodiments, a pharmaceutical composition as described herein are formulated in rectal compositions such as enemas, rectal gels, rectal foams, rectal aerosols, suppositories, jelly suppositories, or retention enemas.

[0187] A formulation disclosed herein can be stable at a temperature of at about 0°C, 5°C, 10°C, 15°C, 20°C, 25°C, 30°C, 35°C, 40°C, 45°C, 50°C, 55°C, 60°C, 65°C, or about 70°C. For example, a formulation disclosed herein can be stable at room temperature (e.g., about 20°C to 25°C).

[0188] A formulation disclosed herein can be stable (e.g., at a temperature described herein) for at least about 1 day, at least about 2 days, at least about 3 days, at least about 4 days, at least about 5 days, at least about 6 days, at least about 1 week, at least about 2 weeks, at least about 3 weeks, at least about 1 month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 5 months, at least about 6 months, at least about 7 months, at least about 8 months, at least about 9 months, at least about 10 months, at least about 11 months, at least about 1 year, at least about 2 years, at least about 3 years, at least about 4 years, at least about 5 years, at least about 6 years, at least about 7 years, at least about 8 years, at least about 9 years, or at least about 10 years. A formulation disclosed herein can be stable for at most about 10 years, at most about 9 years, at most about 8 years, at most about 7 years, at most about 6 years, at most about 5 years, at most about 4 years, at most about 3 years, at most about 2 years, at most about 1 year, at most about 11 months, at most about 10 months, at most about 9 months, at most about 8 months, at most about 7 months, at most about 6 months, at most about 5 months, at most about 4 months, at most about 3 months, at most about 2 months, at most about 1 month, at most about 3 weeks, at most about 2 weeks, at most about 1 week, at most about 6 days, at most about 5 days, at most about 4 days, at most about 3 days, at most about 2 days, or at most about 1 day. For example, the compositions do not exhibit a change (e.g., greater than 5%) in appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 3 months, 6 months, 9 months, or at least 12 months as compared to the original composition after manufacturing. In some embodiments, the pharmaceutical compositions do not exhibit a significant change, as defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), in one or more of appearance, pH, percent impurities, activity (as measured by in vitro assays), or osmolarity over time, e.g., at least 12 months as compared to the original pharmaceutical composition after manufacturing.

[0189] A formulation disclosed herein can be at a pH of from about 5 to about 9. In some embodiments, a formulation disclosed herein can have a pH of about 5, about 5.1, about 5.2, about 5.3, about 5.4, about 5.5, about 5.6, about 5.7, about 5.8, about 5.9, about 6.0, about 6.1, about 6.2, about 6.3, about 6.4, about 6.5, about 6.6, about 6.7, about 6.8, about 6.9, about 7.0, about 7.1, about 7.2, about 7.3, about 7.4, about 7.5, about 7.6, about 7.7, about 7.8, about 7.9, about 8.0, about 8.1, about 8.2, about 8.3, about 8.4, about 8.5, about 8.6, about 8.7, about 8.8, about 8.9, or about 9. In some embodiments, a formulation disclosed herein can have a pH of from about 7 to about 7.5.

[0190] In some embodiments, a pharmaceutical composition as described herein can be a combination of any pharmaceutical compounds described herein with other chemical components, such as carriers, stabilizers, diluents, dispersing agents, suspending agents, thickening agents, and / or excipients.

[0191] Pharmaceutical compositions can be formulated using one or more physiologically-acceptable carriers comprising excipients and auxiliaries, which can facilitate processing of the active compounds into preparations that can be used pharmaceutically. Formulations can be modified depending upon the route of administration chosen.Pharmaceutical compositions comprising any compound as described herein can be manufactured, for example, by mixing, dissolving, granulating (e.g., wet granulation and / or dry granulation), dragee-making, levigating, emulsifying, encapsulating, entrapping, or compression processes.

[0192] A pharmaceutical composition as described herein can include at least one pharmaceutically acceptable carrier, diluent, or excipient and compounds described herein as free-base or pharmaceutically-acceptable salt forms. The methods and pharmaceutical compositions described herein can include the use of crystalline forms (also known as polymorphs), or active metabolites of these compounds having the same type of activity.

[0193] In some embodiments, the pharmaceutical composition includes a fdler. In some embodiments, the filler is selected from among binders, diluents, di sint egrants, glidants, surfactants, and combinations thereof. A pharmaceutical composition, as used herein, can refer to a mixture of a compound disclosed herein with other chemical components (e.g., pharmaceutically acceptable inactive ingredients), such as carriers, excipients, binders, filling agents, suspending agents, flavoring agents, sweetening agents, disintegrating agents, dispersing agents, surfactants, lubricants, colorants, diluents, solubilizers, moistening agents, plasticizers, stabilizers, penetration enhancers, wetting agents, anti-foaming agents, antioxidants, preservatives, or one or more combination thereof. In some embodiments, the pharmaceutical composition facilitates administration of the compound to an organism.

[0194] In some embodiments, the filler includes saccharides (e.g., sugars, starch, and cellulose), gelatin, calcium carbonate, and synthetic polymers (e.g., polyvinylpyrrolidone, polyethylene glycol, and poloxamers (e.g., Pol oxamer 188, a copolymer of polyoxyethylene and polyoxypropylene)). Exemplary fillers include, but are not limited to, glucose, sucrose, lactose, a starch, including modified starches such as sodium starch glycolate (e.g., Explotab®), xylitol, dextrin, saccharose, sorbitol, mannitol (e.g., Parteck® M 200 (mannitol with an average particle size of about 50 tm to about 500 tm) or Parteck® M 100 (mannitolwith an average particle size of less than 212 tm)), a cellulose, a polyvinylpyrrolidone, a polyethylene glycol, a polyvinyl alcohol, a polymethacrylate, dibasic calcium phosphate, magnesium stearate, calcium stearate, sodium stearate, stearic acid, hydrogenated vegetable oils, a mineral oil, sodium lauryl sulfate, magnesium lauryl sulfate, glyceryl palmitostearate, sodium benzoate, sodium stearyl fumarate, colloidal silicon dioxide, sodium benzoate, sodium oleate, sodium acetate, aliginic acid, alginates (e.g., sodium alginate), calcium silicate, and ion exchange resins. Exemplary cellulose fillers include microcrystalline cellulose (e.g., Avicel® PH-101 (microcrystalline cellulose with an average particle size of approximately 50 tm) or Avicel® PH 200 (microcrystalline cellulose with an average particle size of approximately 180 tm)), methyl cellulose, ethyl cellulose, hydroxypropyl cellulose, and hydroxypropylmethylcellulose. Exemplary fillers include cross-linked polyvinylpyrrolidone such as with an average particle size of 90 tm to 130 tm) or with an average particle size of 10 tm to 30 tm). Other fillers known to those of skill in the art are also contemplated as being useful when formulated in the pharmaceutical compositions described herein.

[0195] Non-limiting examples of pharmaceutically-acceptable carriers include, but are not limited to, saline, Ringer's solution and dextrose solution. For solid compositions, nontoxic solid carriers can include, for example, pharmaceutical grades of mannitol, lactose, starch, magnesium stearate, sodium saccharin, talc, cellulose, glucose, sucrose, and magnesium carbonate. Carriers may optionally include antioxidants, buffers, bacteriostats and other common additives. For liquid compositions, the liquid can comprise sterile water and an appropriate amount of a saccharide or polysaccharide. Further carriers can include sustained release preparations such as semipermeable matrices of solid hydrophobic polymers containing a pharmaceutical composition as described herein, where the matrices are in the form of shaped articles, e.g., films, liposomes, microparticles, or microcapsules.

[0196] Methods for the preparation of compositions comprising the compounds described herein include formulating the compounds with one or more inert, pharmaceutically- acceptable excipients or carriers to form a solid, semi-solid, or liquid composition. Solid compositions include, for example, powders, tablets, dissolvable sheets, dispersible granules, capsules, cachets, and suppositories. Liquid compositions include, for example, solutions in which a compound is dissolved, emulsions comprising a compound, or a solution containing liposomes, micelles, or nanoparticles comprising a compound as disclosed herein. Semi-solid compositions include, for example, gels, suspensions and creams. The compositions can be in liquid solutions or suspensions, solid forms suitable for solution or suspension in a liquid prior to use, or as emulsions. These compositions can also contain minor amounts of nontoxic,auxiliary substances, such as wetting or emulsifying agents, pH buffering agents, and other pharmaceutically-acceptable additives.

[0197] An excipient can fill a role as simple and direct as being an inert filler, or an excipient as used herein can be part of a pH stabilizing system or coating to insure delivery of the ingredients safely to the stomach. Non-limiting examples of pharmaceutically-acceptable excipients suitable for use in the invention include granulating agents, binding agents, lubricating agents, disintegrating agents, sweetening agents, glidants, anti -adherents, anti-static agents, surfactants, anti-oxidants, gums, coating agents, coloring agents, flavoring agents, coating agents, plasticizers, preservatives, suspending agents, emulsifying agents, anti-microbial agents, plant cellulosic material and spheronization agents, and any combination thereof.

[0198] Non-limiting examples of pharmaceutically-acceptable excipients can be found, for example, in Remington: The Science and Practice of Pharmacy, Twenty-third Ed (Academic Press, 2020); Hoover, John E., Remington's Pharmaceutical Sciences, Mack Publishing Co., Easton, Pa. 1975; Liberman, H. A. and Lachman, L., Eds., Pharmaceutical Dosage Forms, Marcel Decker, New York, N.Y., 1980; and Pharmaceutical Dosage Forms and Drug Delivery Systems, Seventh Ed. (Lippincott Williams & Wilkins 1999), each of which is incorporated by reference in its entirety. Other excipients known to those of skill in the art are also contemplated as being useful when formulated in the compositions described herein.

[0199] For oral administration, pharmaceutical compositions can be formulated readily by combining the active compounds with pharmaceutically-acceptable carriers or excipients. Such carriers can be used to formulate tablets, powders, dissolvable sheets, pills, dragees, capsules, liquids, gels, syrups, elixirs, slurries, suspensions and the like, for oral ingestion by a subject.

[0200] Pharmaceutical preparations for oral use can be obtained by mixing one or more solid excipient with one or more of the compounds described herein, optionally grinding the resulting mixture, and processing the mixture of granules, after adding suitable auxiliaries, if desired, to obtain tablets or dragee cores. Cores can be provided with suitable coatings. For this purpose, concentrated sugar solutions can be used, which can contain an excipient such as gum arabic, talc, polyvinylpyrrolidone, carbopol gel, polyethylene glycol, and / or titanium dioxide, lacquer solutions, and suitable organic solvents or solvent mixtures. Dyestuffs or pigments can be added to the tablets or dragee coatings, for example, for identification or to characterize different combinations of active compound doses.

[0201] Pharmaceutical preparations which can be used orally include push-fit capsules made of gelatin, as well as soft, sealed capsules made of gelatin and a plasticizer, such as glycerol or sorbitol. In some embodiments, the capsule comprises a hard gelatin capsulecomprising one or more of pharmaceutical, bovine, and plant gelatins. A gelatin can be alkaline-processed. The push-fit capsules can contain the active ingredients in admixture with filler such as lactose, binders such as starches, and / or lubricants such as talc or magnesium stearate and, stabilizers. In soft capsules, the active compounds can be dissolved or suspended in suitable liquids, such as fatty oils, liquid paraffin, or liquid polyethylene glycols. Stabilizers can be added. All formulations for oral administration are provided in dosages suitable for such administration.

[0202] In some embodiments, an oral formulation further comprises a taste-masking agent. In some embodiments, an oral formulation further comprises an aroma compound.

[0203] For buccal or sublingual administration, the compositions can be tablets, dissolvable sheets, lozenges, or gels. For example, Striant® (testosterone) in an extended release buccal tablet may be utilized. The formulation may be modified to include a progesterone (e.g., segesterone acetate) using known methods. These formulations may also be modified to alter the amount of active agent and the amount or type of excipients.

[0204] A composition as described herein can comprise at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1.5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4.1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2%w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7.1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8. 1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9.1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 1 1% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of an excipient.

[0205] A composition as described herein can comprise at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, atmost about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of an excipient.

[0206] A composition as described herein can comprise at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1.5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4.1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at least about 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6. 1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7. 1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8.1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9.1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 11% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at leastabout 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of a carrier.

[0207] A composition as described herein can comprise at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at most about 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v,at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about 0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of a carrier.

[0208] A composition as described herein can comprise at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1.2% w / v, at least about 1.3% w / v, at least about 1.4% w / v, at least about 1.5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at least about 2.5% w / v, at least about 2.6% w / v, at least about 2.7% w / v, at least about 2.8% w / v, at least about 2.9% w / v, at least about 3.0% w / v, at least about 3.1% w / v, at least about 3.2% w / v, at least about 3.3% w / v, at least about 3.4% w / v, at least about 3.5% w / v, at least about 3.6% w / v, at least about 3.7% w / v, at least about 3.8% w / v, at least about 3.9% w / v, at least about 4.0% w / v, at least about 4.1% w / v, at least about 4.2% w / v, at least about 4.3% w / v, at leastabout 4.4% w / v, at least about 4.5% w / v, at least about 4.6% w / v, at least about 4.7% w / v, at least about 4.8% w / v, at least about 4.9% w / v, at least about 5.0% w / v, at least about 5.1% w / v, at least about 5.2% w / v, at least about 5.3% w / v, at least about 5.4% w / v, at least about 5.5% w / v, at least about 5.6% w / v, at least about 5.7% w / v, at least about 5.8% w / v, at least about 5.9% w / v, at least about 6.0% w / v, at least about 6.1% w / v, at least about 6.2% w / v, at least about 6.3% w / v, at least about 6.4% w / v, at least about 6.5% w / v, at least about 6.6% w / v, at least about 6.7% w / v, at least about 6.8% w / v, at least about 6.9% w / v, at least about 7.0% w / v, at least about 7. 1% w / v, at least about 7.2% w / v, at least about 7.3% w / v, at least about 7.4% w / v, at least about 7.5% w / v, at least about 7.6% w / v, at least about 7.7% w / v, at least about 7.8% w / v, at least about 7.9% w / v, at least about 8.0% w / v, at least about 8.1% w / v, at least about 8.2% w / v, at least about 8.3% w / v, at least about 8.4% w / v, at least about 8.5% w / v, at least about 8.6% w / v, at least about 8.7% w / v, at least about 8.8% w / v, at least about 8.9% w / v, at least about 9.0% w / v, at least about 9.1% w / v, at least about 9.2% w / v, at least about 9.3% w / v, at least about 9.4% w / v, at least about 9.5% w / v, at least about 9.6% w / v, at least about 9.7% w / v, at least about 9.8% w / v, at least about 9.9% w / v, at least about 10% w / v, at least about 1 1% w / v, at least about 12% w / v, at least about 13% w / v, at least about 14% w / v, at least about 15% w / v, at least about 16% w / v, at least about 17% w / v, at least about 18% w / v, at least about 19% w / v, at least about 20% w / v, at least about 21% w / v, at least about 22% w / v, at least about 23% w / v, at least about 24% w / v, at least about 25% w / v, at least about 30% w / v, at least about 35% w / v, at least about 40% w / v, at least about 45% w / v, at least about 50% w / v, at least about 55% w / v, at least about 60% w / v, at least about 65% w / v, at least about 70% w / v, at least about 75% w / v, at least about 80% w / v, at least about 85% w / v, at least about 90% w / v, at least about 91% w / v, at least about 92% w / v, at least about 93% w / v, at least about 94% w / v, at least about 95% w / v, at least about 96% w / v, at least about 97% w / v, at least about 98% w / v, at least about 99% w / v, or more of a dilutant.

[0209] A composition as described herein can comprise at most about 99% w / v, at most about 98% w / v, at most about 97% w / v, at most about 96% w / v, at most about 95% w / v, at most about 94% w / v, at most about 93% w / v, at most about 92% w / v, at most about 91% w / v, at most about 90% w / v, at most about 85% w / v, at most about 80% w / v, at most about 75% w / v, at most about 70% w / v, at most about 65% w / v, at most about 60% w / v, at most about 55% w / v, at most about 50% w / v, at most about 45% w / v, at most about 40% w / v, at most about 35% w / v, at most about 30% w / v, at most about 25% w / v, at most about 24% w / v, at most about 23% w / v, at most about 22% w / v, at most about 21% w / v, at most about 20% w / v, at most about 19% w / v, at mostabout 18% w / v, at most about 17% w / v, at most about 16% w / v, at most about 15% w / v, at most about 14% w / v, at most about 13% w / v, at most about 12% w / v, at most about 11% w / v, at most about 10% w / v, at most about 9.9% w / v, at most about 9.8% w / v, at most about 9.7% w / v, at most about 9.6% w / v, at most about 9.5% w / v, at most about 9.4% w / v, at most about 9.3% w / v, at most about 9.2% w / v, at most about 9.1% w / v, at most about 9.0% w / v, at most about 8.9% w / v, at most about 8.8% w / v, at most about 8.7% w / v, at most about 8.6% w / v, at most about 8.5% w / v, at most about 8.4% w / v, at most about 8.3% w / v, at most about 8.2% w / v, at most about 8.1% w / v, at most about 8.0% w / v, at most about 7.9% w / v, at most about 7.8% w / v, at most about 7.7% w / v, at most about 7.6% w / v, at most about 7.5% w / v, at most about 7.4% w / v, at most about 7.3% w / v, at most about 7.2% w / v, at most about 7.1% w / v, at most about 7.0% w / v, at most about 6.9% w / v, at most about 6.8% w / v, at most about 6.7% w / v, at most about 6.6% w / v, at most about 6.5% w / v, at most about 6.4% w / v, at most about 6.3% w / v, at most about 6.2% w / v, at most about 6.1% w / v, at most about 6.0% w / v, at most about 5.9% w / v, at most about 5.8% w / v, at most about 5.7% w / v, at most about 5.6% w / v, at most about 5.5% w / v, at most about 5.4% w / v, at most about 5.3% w / v, at most about 5.2% w / v, at most about 5.1% w / v, at most about 5.0% w / v, at most about 4.9% w / v, at most about 4.8% w / v, at most about 4.7% w / v, at most about 4.6% w / v, at most about 4.5% w / v, at most about 4.4% w / v, at most about 4.3% w / v, at most about 4.2% w / v, at most about 4.1% w / v, at most about 4.0% w / v, at most about 3.9% w / v, at most about 3.8% w / v, at most about 3.7% w / v, at most about 3.6% w / v, at most about 3.5% w / v, at most about 3.4% w / v, at most about 3.3% w / v, at most about 3.2% w / v, at most about 3.1% w / v, at most about 3.0% w / v, at most about 2.9% w / v, at most about 2.8% w / v, at most about 2.7% w / v, at most about 2.6% w / v, at most about 2.5% w / v, at most about 2.4% w / v, at most about 2.3% w / v, at most about 2.2% w / v, at most about 2.1% w / v, at most about 2.0% w / v, at most about 1.9% w / v, at most about 1.8% w / v, at most about 1.7% w / v, at most about 1.6% w / v, at most about 1.5% w / v, at most about 1.4% w / v, at most about 1.3% w / v, at most about 1.2% w / v, at most about 1.1% w / v, at most about 1.0% w / v, at most about 0.9% w / v, at most about 0.8% w / v, at most about 0.7% w / v, at most about 0.6% w / v, at most about 0.5% w / v, at most about 0.4% w / v, at most about 0.3% w / v, at most about 0.2% w / v, at most about 0.1% w / v, at most about 0.09% w / v, at most about 0.08% w / v, at most about 0.07% w / v, at most about 0.06% w / v, at most about 0.05% w / v, at most about 0.04% w / v, at most about 0.03% w / v, at most about 0.02% w / v, at most about 0.01% w / v, at most about 0.009% w / v, at most about 0.008% w / v, at most about 0.007% w / v, at most about 0.006% w / v, at most about 0.005% w / v, at most about0.004% w / v, at most about 0.003% w / v, at most about 0.002% w / v, at most about 0.001% w / v, or less of a dilutant.

[0210] A composition as described herein can comprise at least about 0.001% weight by volume (w / v), at least about 0.002% w / v, at least about 0.003% w / v, at least about 0.004% w / v, at least about 0.005% w / v, at least about 0.006% w / v, at least about 0.007% w / v, at least about 0.008% w / v, at least about 0.009% w / v, at least about 0.01% w / v, at least about 0.02% w / v, at least about 0.03% w / v, at least about 0.04% w / v, at least about 0.05% w / v, at least about 0.06% w / v, at least about 0.07% w / v, at least about 0.08% w / v, at least about 0.09% w / v, at least about 0.1% w / v, at least about 0.2% w / v, at least about 0.3% w / v, at least about 0.4% w / v, at least about 0.5% w / v, at least about 0.6% w / v, at least about 0.7% w / v, at least about 0.8% w / v, at least about 0.9% w / v, at least about 1.0% w / v, at least about 1.1% w / v, at least about 1 .2% w / v, at least about 1 .3% w / v, at least about 1 .4% w / v, at least about 1.5% w / v, at least about 1.6% w / v, at least about 1.7% w / v, at least about 1.8% w / v, at least about 1.9% w / v, at least about 2.0% w / v, at least about 2.1% w / v, at least about 2.2% w / v, at least about 2.3% w / v, at least about 2.4% w / v, at leas...

Claims

1. CLAIMSWHAT IS CLAIMED IS:

1. A composition for contraceptive treatment of males, comprising: a) a first compound, wherein the first compound comprises testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof, and b) a second compound, wherein the second compound comprises segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof, wherein the composition is a non-topical composition.

2. The composition of claim 1, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is naturally-derived.

3. The composition of claim 1, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is synthetic.

4. The composition of any one of claims 1-3, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg to about 200 mg.

5. The composition of any one of claims 1-4, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 73.8 mg.

6. The composition of any one of claims 1-4, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 36.39 mg.

7. The composition of any one of claims 1-6, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg / mL to about 25 mg / mL.

8. The composition of claim 7, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 10 mg / mL to about 20 mg / mL.

9. The composition of any one of claims 1-8, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 0.5% to about 4% wt / wt.

10. The composition of claims 1-9, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.6% wt / wt.

11. The composition of claims 1-9, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.697% wt / wt.

12. The composition of claims 1-9, wherein the testosterone, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 1.7% wt / wt.

13. The composition of any one of claims 1-12 wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is naturally-derived.

14. The composition of any one of claims 1-12 wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is synthetic.

15. The composition of any one of claims 1-14, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about Img to about 200 mg.

16. The composition of any one of claims 1-14, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is about 8.2 mg.

17. The composition of any one of claims 1-14, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is about 4.1 mg.

18. The composition of any one of claims 1-17, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about Img / mL to about 4mg / mL.

19. The composition of any one of claims 18, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about 1 mg / mL to about 2 mg / mL.

20. The composition of any one of claims 1-19, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of from about .01% to about 0.5% wt / wt.

21. The composition of any one of claims 1-20, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.1% wt / wt.

22. The composition of any one of claims 1-20, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.19% wt / wt.

23. The composition of any one of claims 1-20, wherein the segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof is in an amount of about 0.2% wt / wt.

24. The composition of any one of claims 1-23, wherein the non-topical composition is formulated into a solution, liquid suspension, a lotion, a gel, a paste, a shampoo, a scrub, a rub, a smear, a medicated stick, a medicated bandage an implantable device or a cream.

25. The composition of any one of claims 1-23, wherein the non-topical composition is formulated as an injectable composition, an oral composition, an inhalablecomposition, an intranasal composition, an implantable composition or a sublingual composition.

26. The composition of any one of claims 1-25, wherein the composition is the injectable composition.

27. The composition of any one of claims 1-26, wherein the composition is in a liquid dosage form.

28. The composition of any one of claims 1-27, wherein the injectable composition is formulated for intramuscular, intravenous, subcutaneous, intraosseous or intradermal injection.

29. The composition of any one of claims 1-25, wherein the composition is the oral composition or the sublingual.

30. The composition of claim 29, wherein the composition is in a solid dosage form.

31. The composition of claim 29, wherein the composition is in a gel dosage form.

32. The composition of claim 31 , wherein the gel dosage form is formulated for intranasal delivery.

33. The composition of claim 29, wherein the composition is in the form of a pill.

34. The composition of claim 29, wherein the composition is in the form of a powder.

35. The composition of claim 34, wherein the powder is designed as an additive to a food or a drink.

36. The composition of claim 29, wherein the composition is in the form of a gum, paste or liquid.

37. The composition of any one of claims 1-25, wherein the composition is the inhalable composition.

38. The composition of claim 37, wherein the composition is a liquid suspension or solution.

39. The composition of any one of claims 37-38, wherein the inhalable composition is nebulized.

40. The composition of claim 37, wherein the inhalable composition is in a gaseous dosage form.

41. The composition of claim 37, wherein the inhalable composition is formulated for inhalation by mouth.

42. The composition of claim 37, wherein the inhalable composition is formulated for nasal inhalation.

43. The composition of any one of claims 1-25, wherein the composition is implantable.

44. The composition of claim 43, wherein the composition is formulated in a subdermal implant.

45. The composition of claim 44, wherein the subdermal implant comprises a polymer.

46. The composition of claim 45, wherein the polymer is biodegradable.

47. The composition of claim 45, wherein the polymer is not biodegradable.

48. The composition of any one of claims 1-47, further comprising a therapeutic agent.

49. The composition of claim 48, wherein the therapeutic agent is a contraceptive.

50. The composition of claim 48, wherein the therapeutic agent is a spermicide.

51. The composition of claim 48, wherein the therapeutic agent is for use in treating a sexually-transmitted disease (STD).

52. The composition of any one of claims 48-51, wherein the therapeutic agent is for use in preventing a STD.

53. The composition of claim 51 or 52, wherein the STD is gonorrhea, syphilis, trichomoniasis, pelvic inflammatory disease, lymphogranuloma venereum, mycoplasma genitalium, bacterial vaginosis, or chlamydia.

54. The composition of claim 51 or 52, wherein the STD is human immunodeficiency virus (HTV), herpes, genital herpes, hepatitis B, viral hepatitis, human papillomavirus (HPV), molluscum contagiosum virus (MCV), or zika virus.

55. The composition of claim 51 or 52, wherein the STD is scabies or public lice.

56. The composition of any one of claims 48-55, wherein the therapeutic agent is an antiviral.

57. The composition of any one of claims 48-55, wherein the therapeutic agent is an antibiotic.

58. The composition of any one of claims 48-57, wherein the therapeutic agent is an antibody.

59. The composition of any one of claims 48-57, wherein the therapeutic agent is a compound.

60. The composition of any one of claims 1-59, further comprising a pharmaceutically acceptable excipient.

61. The composition of any one of claims 1-60, further comprising a taste-masking additive.

62. The composition of any one of claims 1-61, further comprising an aroma compound.

63. The composition of any one of claims 1-62, wherein the composition is formulated for daily use, twice daily use, weekly use, twice weekly use, use every other day, use every two days, monthly use or yearly use.

64. The composition of any one of claims 1-63, wherein the first compound and the second compound are formulated as a single composition.

65. The composition of any one of claims 1-63, wherein the first compound and the second compound are formulated as separate compositions.

66. A method for contraceptive treatment of males, the method comprising administering to a subject in need thereof the composition of any one of claims 1-65.

67. A method for treating acne, the method comprising administering to a subject in need thereof the composition of any one of claims 1-65.

68. A method for treating sexual dysfunction, the method comprising administering to a subject in need thereof the composition of any one of claims 1-65.

69. A method for increasing libido, the method comprising administering to a subject in need thereof the composition of any one of claims 1-65.

70. The method of any one of claims 66-69, wherein the administering does not affect serum testosterone levels in the subject.

71. The method of any one of claims 66-69, wherein serum testosterone levels in the subject are maintained at a concentration of about 300 nanograms per deciliter (ng / dL) to about 1,000 ng / dL.

72. The method of any one of claims 66-69, wherein serum testosterone concentration in the subject is maintained between about 400 and 1050 ng testosterone per dL serum.

73. The method of any one of claims 66-69, wherein the serum testosterone concentration is maintained between about 200 and 1800 ng testosterone per dL serum.

74. The method of any one of claims 66-69, wherein serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after the administering and ending about 24 hours after the administering.

75. The method of any one of claims 66-69, wherein serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time period beginning about 0.5 hours after the administering and ending about 48 hours after the administering.

76. The method of any one of claims 66-69, wherein serum concentration of testosterone in the subject is greater than about 300 ng per dL serum during a time periodbeginning about 0.5 hours after the administering and ending about 72 hours after the administering.

77. The method of any one of claims 66-76, wherein the administering suppresses luteinizing hormone (LH) in the subject.

78. The method of any one of claims 66-77, wherein the administering suppresses follicle stimulating hormone (FSH) in the subject.

79. The method of any one of claims 66-78, wherein the administering decreases endogenous testosterone secretion in testes of the subject.

80. The method of any one of claims 66-79, wherein the administering decreases the incidence of acne of a subject by at least about 10%, 20%, 30%, 40%, 50% as compared to a subject not having the composition or having a composition comprising a lower dose of testosterone.

81. The method of any one of claims 66-80, wherein the effects of the composition are reversible within a week, a month, 3 months, 6 months, or 1 year after halting administration of the composition to the subject.

82. The method of any one of claims 66-81, wherein the first compound and the second compound are administered to the subject as a single composition or a separate composition.

83. The method of claim 82, wherein the first compound and the second compound are administered to the subject simultaneously or sequentially.

84. The method of any one of claims 66-83, wherein the administering to the subject is once, twice, or three times daily for at least 5 days.

85. The method of any one of claims 66-83, wherein the administering to the subject is once, twice, three or four times per month for at least 5 months.

86. A kit comprising the composition of any one of claims 1 to 65 and instructions for use.

87. A method for contraceptive treatment of a subject, comprising maintaining serum nesterone levels in the subject equal to or higher than 600 pmol / L by transdermal deposition delivery via an implanted device or depositable substance configured to deliver an appropriate amount of segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof to the subject.

88. The method of claim 87 wherein the implanted device comprises one or more subdermal rods.

89. The method of claim 88 wherein the number, size, and / or shape of the subdermal rods used is determined by the intended amount of segesterone acetate, derivative thereof, or pharmaceutically acceptable salt thereof to be delivered to the subject.

90. The method of claim 89 wherein the intended amount is an amount sufficient to delivery between 20-300 pg / day of segesterone acetate, the derivative thereof, or the pharmaceutically acceptable salt thereof to the subject for the length of an intended delivery window.

91. The method of claim 87 wherein the intended delivery window is one week.

92. The method of claim 87 wherein the intended delivery window is one month.

93. The method of claim 87 wherein the intended delivery window is six months.

94. The method of claim 87 wherein the intended delivery window is 52 weeks.

95. The method of claim 87 comprising co-administering testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof to the subject.

96. The method of claim 87 wherein the testosterone is delivered non-topically.

97. The method of claim 87 wherein the testosterone, derivative thereof or pharmaceutically acceptable salt thereof is delivered via an implanted device or depositable substance.

98. The method of claim 97 wherein the testosterone, derivative thereof or pharmaceutically acceptable salt thereof and segesterone acetate, derivative thereof, or pharmaceutically acceptable salt thereof are delivered via the same implanted device or depositable substance.

99. The method of claim 87 further comprising periodically replacing the implanted device.

100. The method of claim 99 comprising explanting the implanted device prior to implanting a second implanted device.101 . The method of claim 99 wherein the timeframe for periodically replacing the implanted device is determined by the intended delivery window.

102. The method of claim 99 wherein the timeframe for periodically replacing the implanted device is determined by measuring the subject’s serum nesterone levels and identifying that the subject’s serum nesterone levels are below a specific threshold.

103. The method of claim 99 wherein the timeframe for periodically replacing the implanted device is determined by measuring the subject’s serum testosterone levels and identifying that the subject’s serum testosterone levels are below a specific threshold.

104. The method of claim 100 wherein the implanted device is fortified so as to prevent fragmentation upon explant.

105. The method of claim 104 wherein the fortification includes the inclusion of barrier layers, reinforcement fibers, or a specific endcap design.

106. The method of claim 87 wherein the depositable substance comprises an oilbased vehicle.

107. A method for contraceptive treatment of a subject, comprising maintaining serum nesterone levels in the subject equal to or higher than 600 pmol / L by periodic parenteral injection of an appropriate amount of segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof to the subject.

108. The method of claim 107 wherein the periodic injection is given one or more times per week.

109. The method of claim 107 wherein the periodic injection is given weekly.

110. The method of claim 107 further comprising measuring the serum nesterone levels in the subject and giving additional segesterone acetate, a derivative thereof, or a pharmaceutically acceptable salt thereof to the subject if the serum nesterone levels drop below a particular threshold.

111. The method of claim 110 wherein the additional segesterone acetate, derivative thereof, or pharmaceutically acceptable salt thereof is delivered non-topically.

112. The method of claim 111 wherein the additional segesterone acetate, derivative thereof or pharmaceutically acceptable salt thereof is delivered via parenteral injection.

113. The method of claim 107 further comprising co-administering testosterone, a derivative thereof, or a pharmaceutically acceptable salt thereof to the subject.1 14. The method of claim 1 13 wherein the testosterone, derivative thereof or pharmaceutically acceptable salt thereof is administered non-topically.

115. The method of claim 114 wherein the testosterone, derivative thereof or pharmaceutically acceptable salt thereof is administered as a parenteral injection.

116. The method of claim 115 wherein the segesterone acetate, derivative thereof or pharmaceutically acceptable salt thereof and testosterone, derivative thereof or pharmaceutically acceptable salt thereof are co-formulated into the same injectable dose.

117. A method of contraceptive treatment of a subj ect, comprising maintaining serum nesterone levels in the subject equal to or higher than 600 pmol / L by by perodic delivery of segesterone acetate, derivative thereof or pharmaceutically acceptable salt thereof via a combination of two or more non-topical delivery methods.

118. The method of claim 117 wherein a first delivery method delivers first dosage and second dosages for first and second delivery windows and a second delivery method is used to maintain a baseline delivery rate of the segesterone acetate, derivative thereof or pharmaceutically acceptable salt thereof at the end of the first delivery window, at the beginning of the second delivery window, and / or in between the first and second delivery windows.

119. The method of claim 118 wherein the first delivery method is a parenteral injection and the second delivery method is via an implantable device or depositable substance.

120. An auto-injection device comprising one or more preloaded doses of a composition of any of claims 1 to 65.

121. Use of a composition or device or kit of any of the above claims.

122. The use of claim 121, to treat a disease or condition or alter fertility.

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