Methods for treating endometriosis and methods for providing effective contraception
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- キーモ リサーチ エセエレ
- Filing Date
- 2026-03-19
- Publication Date
- 2026-06-23
AI Technical Summary
が有効成分又は医薬組成物の任意の毒性又は有害作用を上回る量のことである。
Smart Images
Figure 2026102833000003 
Figure 2026102833000004 
Figure 2026102833000001
Abstract
Claims
1. Drospirenone for use in a method of treating endometriosis, endometriosis-associated pelvic pain (EAPP) and / or dysmenorrhea in female subjects, comprising administering drospirenone to a subject in a two-phase regimen, wherein the daily dose of drospirenone administered from day 1 to day 24 is about 2.0 mg to 6.0 mg, preferably about 3.0 mg to 5.0 mg, more preferably about 3.5 mg to 4.5 mg, even more preferably about 3.8 mg to 4.2 mg, most preferably about 4.0 mg of drospirenone, and the lower daily dose of drospirenone administered from day 25 to day 28 is about 2.5 mg to 3.5 mg, preferably about 2.6 mg to 3.2 mg, more preferably about 3.0 mg, most preferably about 2.8 mg of drospirenone.
2. Drospirenone used in a method for treating endometriosis, endometriosis-associated pelvic pain (EAPP), and / or dysmenorrhea, according to claim 1, wherein the daily dose of drospirenone administered from day 1 to day 24 is 4.0 mg, and the lesser daily dose of drospirenone administered from day 25 to day 28 is 2.8 mg.
3. Drospirenone used in a method for treating endometriosis, endometriosis-associated pelvic pain (EAPP), and / or dysmenorrhea according to claim 1 or 2, wherein the treatment also provides contraception.
4. The use of drospirenone as a contraceptive, comprising administering drospirenone in a two-phase regimen, wherein a daily dose of drospirenone is administered during the first phase, and a lower daily dose of drospirenone is administered during the second phase, preferably such that the administration of drospirenone induces amenorrhea.
5. The use of drospirenone according to claim 4, wherein the aforementioned daily dose of drospirenone is administered once daily from day 1 to day 24, and thereafter, a smaller daily dose of drospirenone is administered once daily from day 25 to day 28.
6. The use of drospirenone according to claim 5, wherein the daily dose of drospirenone administered from day 1 to day 24 is about 2.0 mg to 6.0 mg, preferably about 3.0 mg to 5.0 mg, more preferably about 3.5 mg to 4.5 mg, even more preferably about 3.8 mg to 4.2 mg, and most preferably about 4.0 mg of drospirenone.
7. The use of drospirenone according to any one of claims 4 to 6, wherein the daily dose of drospirenone administered from day 25 to day 28 is less than the aforementioned amount of drospirenone, which is about 2.5 mg to about 3.5 mg, preferably about 2.6 mg to about 3.2 mg, more preferably about 3.0 mg, and most preferably about 2.8 mg.
8. A kit, preferably a contraceptive kit, comprising one or more packaging units, each packaging unit comprising at least 28 active daily dose units, a) At least 24 daily dose units each contain a first amount of drospirenone, and each of these daily dose units contains the same amount of drospirenone, and the amount is greater than the amount of drospirenone in a daily dose unit of a second amount of drospirenone. b) At least four daily dose units each contain the second amount of drospirenone, and each of these daily dose units contains the same amount of drospirenone, wherein the amount of drospirenone is less than that of a daily dose unit containing the first amount of drospirenone. kit.
9. The aforementioned at least 28 active daily dose units do not contain estrogen, and preferably contain d The kit according to claim 8, wherein rosspirenone is the sole contraceptive active ingredient in the at least 28 active daily dose units.
10. The kit according to claim 8 or 9, wherein the first amount of drospirenone is about 2.0 mg to 6.0 mg, preferably about 3.0 mg to 5.0 mg, more preferably about 3.5 mg to 4.5 mg, even more preferably about 3.8 mg to 4.2 mg, and most preferably about 4.0 mg of drospirenone.
11. The kit according to any one of claims 8 to 10, wherein the second amount of drospirenone is about 2.5 mg to about 3.5 mg, preferably about 2.6 mg to about 3.2 mg, more preferably about 3.0 mg, and most preferably about 2.8 mg of drospirenone.
12. A pharmaceutical composition comprising drospirenone for use in a method for treating endometriosis, endometriosis-associated pelvic pain (EAPP), and / or dysmenorrhea according to any one of claims 1 to 3, wherein the pharmaceutical composition further comprises one or more pharmaceutically acceptable additives, preferably the pharmaceutically acceptable additives being at least one binder and at least one filler. (i) The amount of drospirenone is between 1% and 10% by weight, (ii) The amount of the at least one binder is 50% to 65% by weight, (iii) The amount of the at least one filler is 25% to 35% by weight, The aforementioned weight percentage refers to the total weight of the pharmaceutical composition. Pharmaceutical composition.
13. Further comprising at least one lubricant and at least one lubricating agent, (iv) The amount of the at least one lubricant is 0.2% to 6% by weight, (v) The amount of the at least one lubricant is 0.2% to 0.6% by weight, The aforementioned weight percentage refers to the total weight of the pharmaceutical composition. A pharmaceutical composition for use according to claim 12.
14. (i) The at least one binder is microcrystalline cellulose, (ii) The at least one filler is anhydrous lactose, (iii) The at least one lubricant is silicon dioxide, (iv) The at least one lubricant is magnesium stearate. A pharmaceutical composition for use according to claim 12 or 13.
15. The use of drospirenone as a contraceptive according to any one of claims 4 to 7 in the pharmaceutical composition according to any one of claims 12 to 14.