Phase III success for Androxal (Repros Therapeutics) for Hypogonadism

Repros Therapeutics Inc. reported top-line results for the first pivotal study of Androxal, ZA-301, in the treatment of secondary Hypogonadism. Results for the Intent-to-Treat population met both co-primary endpoints mandated by the FDA. The Intent-to-Treat population included all men randomized in the study whether or not they completed the study. 151 subjects were randomized into the study, 38 on placebo and 113 on Androxal.The primary testosterone endpoint required that 75% of the subjects in the drug arm exhibit a 24 hour average total testosterone in the normal range (300-1040 ng/dL) at the end of 12 weeks of treatment.

79% of the Intent-to-Treat Androxal subjects exhibited 24 hour average testosterone levels in the normal range. Importantly, not a single subject exhibited any testosterone assessment at any time that was above the normal range. This included any of the individual assessments made during the 24 hour sampling. This finding is a particularly important safety assessment for the FDA during their review of any treatment for Hypogonadism.