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Combination therapy for treating androgen deficiency

A technology of androgen, therapeutic agent, applied in the field of combination therapy

Inactive Publication Date: 2014-12-24
REPROS THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Specifically, exogenous administration of testosterone leads to inhibition of endogenous testosterone release through feedback inhibition of pituitary LH

Method used

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  • Combination therapy for treating androgen deficiency
  • Combination therapy for treating androgen deficiency
  • Combination therapy for treating androgen deficiency

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Effects of Clomid on Serum Testosterone and Cholesterol in Male Baboons

[0065] Adult male baboons were administered 1.5 mg / kg of Clomid, Enclomid (trans-Clomid) or Zuclomid (cis-Clomid) for 12 consecutive days. The samples analyzed were sera taken on the day of the first treatment (day 0), 12 days after treatment (day 12) and 7 days after the last treatment (endpoint or washout) before administration of the test article.

[0066] 1. Effects on body weight and serum LH, FSH, PRL and testosterone

[0067] In the group receiving Enclomid, total serum testosterone increased significantly. See Table 1. There were no differences between groups at baseline or at day 0. Seven days after treatment (the washout period), there were also no differences between the three groups. However, Enclomid produced higher levels of testosterone at day 6 compared to Clomid and Zuclomid (p=0.03 and p=0.00002, respectively) and at day 12 compared to Zuclomid (p=0.047). Zuclomid appare...

Embodiment 2

[0088] Method for increasing testosterone levels in men using trans-clomiphene and a mixture of trans-clomiphene and cis-clomiphene in a ratio greater than 1

[0089] Before administration of trans-clomiphene, blood samples were taken from the male subjects and measured using the method described in, for example, Matsumoto, et al. Clin. Endocrinol. Metab. 56; 720 (1983) (incorporated herein by reference) Testosterone levels. Sex hormone-binding globulin (SHBG), either free or bound to testosterone, can also be measured as described, for example, by Tenover et al. J. Clin. Endocrinol. Metab. 65: 1118 (1987), which describes 3 H] Dihydrotestosterone saturation analysis and measurement of SHBG by radioimmunoassay. Testosterone levels not bound to SHBG (bioavailable testosterone) are also measured, eg according to Tenover et al. J. Clin. Endocrinol and Metab. 65: 1118 (1987). See also Soderguard et al. J. Steroid Biochem 16:801 (1982), which is incorporated herein by reference. ...

Embodiment 3

[0092] Androxal TM and contrast

[0093] A placebo-controlled challenge study was conducted at the Advanced Biological Research, Inc. (ABR) Clinical Research Center in Hackensack, New Jersey, USA to compare orally administered Androxal in hypogonadal men. TM (trans-clomiphene) and (Solvay Pharmaceuticals, Inc.) consists of a cream that administers exogenous testosterone in a transdermal matrix.

[0094] The study recruited 62 hypogonadal men with testosterone levels less than 300ng / dl (normal value 298-1034ng / dl), randomly divided them into 6 groups, and received three doses of Androxal TM (12.5mg, 25mg and 50mg), placebo, and high and low doses of in each Androxal TM Half of the men in the treatment group and the placebo group were randomly divided into cohorts, and these cohorts were entered into the clinic period on days 1 and 14 to determine the Androxal TM Pharmacokinetic parameters and circulating changes of testosterone. Placebo and Androxal administe...

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Abstract

The present invention relates to a combination therapy for elevating testosterone levels in male mammals in which an antiestrogen or pharmaceutically acceptable salt thereof is co-administered to the mammal with an additional therapeutic agent selected from an androgen and an aromatase inhibitor. The invention is also directed to a combination therapy for treating males with hypogonadism and disorders related thereto, including reduction of muscle mass. limitation of body performance capacity, reduction of bone density, reduction of libido, reduction of potency, reduction of benign prostatic hyperplasia and infertility.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 61 / 604,989, filed February 29, 2012, the contents of which are incorporated herein by reference. technical field [0003] The present invention relates to a combination therapy in which an antiestrogen or a pharmaceutically acceptable salt thereof is co-administered with an additional pharmaceutically active agent selected from androgens and aromatase inhibitors in order to increase testosterone levels and / or treat Disorders associated with testosterone deficiency. The present invention also relates to a kit comprising an antiestrogen or a pharmaceutically acceptable salt thereof with exogenous testosterone and / or one or more aromatase inhibitors. Background technique [0004] Testosterone is the primary male androgen and plays a key role in a man's overall health. Testosterone is necessary for the development and maintenance of certain reproducti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/568A61K31/138A61K45/06
CPCA61K31/138A61K31/568A61K45/06A61P3/04A61P3/10A61P5/26A61P5/32A61P15/00A61P15/08A61P19/10A61P21/00A61P43/00A61K2300/00
Inventor J. S. 波多尔斯基R. D. 维勒
Owner REPROS THERAPEUTICS
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