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79-83% in normal testosterone (T) range (FDA requirement 75%)
No patient elevated beyond normal range
Androxal's impact on sperm concentration meets FDA non-inferiority threshold compared to placebo
Potential key points of differentiation from gels
THE WOODLANDS, Texas, March 27, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.
® (Nasdaq:RPRX) 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.
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 subjects had no visit after the randomization visit and their baseline data was carried forward.
After six weeks of dosing, men were allowed to up-titrate if their morning testosterone was below 300 ng/dL. No up-titrations were allowed after that point. 21 of the 113 subjects in the Androxal arm up-titrated from the 12.5 to the 25 mg dose. Some of the men that were not up-titrated exhibited only a marginal response to the 12.5 mg dose.
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.