Repros says Androxal achieved both primary endpoints in the study with statistical significance. However, the company left a lot of data undisclosed and questions about the conduct of the study unanswered.
On the testosterone endpoint, Repros says 79% of the intent-to-treat, Androxal-treated men exhibited 24-hour testosterone levels that were in the normal range after 12 weeks, therefore exceeding the 75% threshold.
Repros did not disclose the mean or median testosterone levels for the men treated with Androxal in the study, nor did the company say anything about how the men treated with placebo performed with respect to testosterone levels.
In a separate "completers" analysis, 83% of men treated with Androxal had a mean 24-hour testosterone of 425 ng/dl, Repros said.
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