- Abstract Title: Evaluation of Enclomiphene (Androxal®) and Testim® on Testosterone (T), Pituitary Hormones and Sperm Function
- Presenters: Dr. John Dean (Past President International Society of Sexual Medicine), Dr. Andrew McCullough (Urological Institute of North Eastern NY)
- Key Conclusions: The study shows that Androxal may provide effective therapy in men with secondary hypogonadism, particularly in those wishing to preserve reproductive status; clinically significant suppression of spermatogenesis in topical testosterone group
THE WOODLANDS, Texas, March 25, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc. ® (Nasdaq:RPRX) today announced that the American Urological Association (AUA) has accepted key data on Androxal for presentation at the annual meeting in San Diego, CA, May 4-8 th, 2013. The data presented are from a double-blind, placebo and active control study of two doses of Androxal (12.5 and 25mg) with open label on demand Testim gel in 120 patients with secondary hypogonadism over a 3 month period.
Androxal acts at the level of the pituitary as a selective estrogen receptor modulator (SERM) to block the negative feedback of estrogen on the pituitary hormones (LH and FSH). Restoration of LH (secondary hypogonadal males having low levels) should provide rapid and effective normalization of T levels without excursion into the supra normal range. In addition, preservation of FSH levels in Androxal treated patients should ensure that there is no negative impact on sperm function. Overall, this study shows that Androxal may provide effective therapy in men with secondary hypogonadism, particularly in those wishing to preserve fertility.
Andrew McCullough, MD, Professor of Urology/Division of Surgery, Albany Medical College noted, "For decades the treatment of hypogonadism has been limited to testosterone replacement. Acceptance of this data as a podium presentation into a special "late breaking" session is important and may represent the beginning of a paradigm shift in the primary treatment of hypogonadism. As in diabetes, where replacement of insulin is second line to oral hypoglycemic agents, perhaps stimulation of endogenous testosterone production should represent the first line treatment of hypogonadism, not only in the infertile man but also with late onset hypogonadism. The importance of the diagnosis and treatment of hypogonadism is increasingly recognized by the urologic and endocrine societies. The importance of the correct treatment of hypogonadism is evidenced by the plenary session at the AUA entitled Critical Discussion: Exogenous Testosterone, A Preventable Cause of Male Infertility."About Repros Therapeutics Inc. ® Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.