Repros Initiates a Comparative Phase 2b Study of Androxal

THE WOODLANDS, Texas -- Repros Therapeutics Inc. (NasdaqGM:RPRX) has reported that the clinical sites have been initiated for its Phase 2b clinical study monitoring the effects of the company's oral drug Androxal® on male fertility and testicular function in patients being treated for low testosterone as compared to Testim®, a popular marketed topical testosterone medication. Enrollment of the 24 patients will commence at two sites in the New York City area shortly. The study is being conducted by Dr. Jed Kaminetsky in New York City and Dr. Michael Werner in Purchase, NY.

All subjects will have been previously diagnosed with secondary hypogonadism and treated with topical testosterone for at least 6 months but not more than 2 years. Patients will be instructed to discontinue their topical testosterone use and return to the clinic within 7 to 21 days. If their morning testosterone is less than 300 ng/dl, they will be randomized to either Androxal or Testim. Patients will be treated for 6 months with results assessed at both the 3 and 6 month time points.

The primary endpoints for the study will be the change in semen volume, sperm count and motility from baseline comparing the Androxal and Testim groups. Secondary endpoints will consist of changes in pituitary hormones as well as testosterone.

In a previous 6 month study, Androxal has been shown to normalize testicular function and be non-inferior to the leading prescribed topical testosterone medication Androgel®. In that study, a once-daily oral dosage of 25 mg Androxal yielded a statistically significant improvement in morning testosterone as compared to Androgel (p=0.0009). In that same study, Androxal showed statistically significant differences in pituitary hormones that are drivers of testicular function as well as testicular size, a surrogate of spermatogenesis.

Joseph S. Podolski commented, “In our previously completed Androxal study, over 30% of our men were less than 50 years of age. There were as many men in their 40’s as there were in their 60’s and the youngest man was 18. It was illuminating that in this clinical trial less than 5% of the 600 patients screened were characterized as having primary testicular failure as determined by elevated LH, the pituitary hormone responsible for driving the testicular production of testosterone. Men with secondary hypogonadism respond to the administration of exogenous testosterone with suppression of the pituitary hormones responsible for the production of testosterone and spermatogenesis, thus impairing fertility further. We believe that Androxal can provide an effective option for men with low testosterone who wish to preserve their fertility.”

He further commented, “Our goal is to request an end of Phase II meeting with the FDA once this study is completed before moving into Phase III studies.”

About Repros Therapeutics Inc.
Repros Therapeutics focuses on the development of oral small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.