Repros Therapeutics reported it has received Institutional Review Board (IRB) approval to commence a Phase 2b study of Androxal (enclomiphene) in men with secondary hypogonadism. The study will enroll up to 120 men with morning testosterone levels <250 ng/dl at 20 sites across the U.S. The men must be naïve to testosterone therapy or have not used testosterone for at least 6 months. The men will be equally randomized to four different groups, double blind Androxal 12.5 mg and 25 mg, matching placebo and open label Testim used per manufacturer’s recommendations. Men will be dosed for 3 months. The primary efficacy endpoint of the study is change in morning testosterone levels comparing the baseline visit to the levels achieved after three months to those achieved for placebo. Changes in pituitary hormones that control testicular function will be assessed as secondary efficacy measures.
Androxal is an orally active small molecule under development that restores normal pituitary response in men resulting in normalization of testosterone and luteinizing hormone (LH) levels.
For more information call (281) 719-3400 or visit www.reprosrx.com.