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news.Repros Therapeutics has got Institutional Review Board (IRB) approval for the initiation of Androxal Phase II study in men with secondary hypogonadism.
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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.
Repros expects to recruit approximately 120 men with morning testosterone levels < 250ng/dl in the trial.
In the trial, men will be equally randomized to four different groups, double blind Androxal 12.5mg and 25mg, matching placebo and open label Testim used per manufacturer’s recommendations.
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.
The secondary efficacy o f the trial is the investigation of changes in pituitary hormones that control testicular function.
Previous studies comparing Androxal to topical testosterone preparations showed suppression of pituitary hormones that regulate testicular function by the replacement therapies.