Repros Reports Both Primary Endpoints Successfully Met in Androxal Study

Repros Therapeutics

today 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. Testosterone Endpoint 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. Any subjects that dropped out of the trial before the 24 hour assessment were to have their last observation carried forward. Men who dropped out before their first visit following the randomization visit carried their baseline observation forward. All 113 men in the Androxal arm were included in the Intent-to-Treat population. Six of the subjects discontinued prematurely. Four of these