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Repros' Androxal Shows Highly Statistically Significant Positive,Effects in Men with Secondary Hypogonadism

THE WOODLANDS, Texas--(BUSINESS WIRE)--Jun 5, 2007 - Repros Therapeutics Inc. (NasdaqGM:RPRX) announced topline results of a six month U.S. Phase 3 study of Androxal(TM), an oral drug being developed to restore normal testicular function in men with secondary hypogonadism. Further, Androxal demonstrates non-inferiority in all the endpoints of the study, compared to Androgel(R), a cream which is the leading treatment for low testosterone.

Study Details and Results

This six month, double-blind study compared two doses of oral Androxal, 12.5mg and 25mg, to matching placebo capsules and open label Androgel at any dose to be used per manufacturer's instructions. The study's primary efficacy endpoint was the proportion of patients at month three who showed morning total serum testosterone concentrations within the normal physiological range (300 to 1040 ng/dl). This endpoint was also extended to include the outcome at month six as well as the assessment of non-inferiority to Androgel.

Of the 191 patients enrolled in the trial, 144 patients completed the study. There were 8 and 15 premature drop outs in the 12.5mg and 25mg Androxal arms, respectively, 15 drop outs in the placebo arm, and 13 drop outs in the Androgel arm. There were no drop outs due to an adverse event or lack of compliance in the Androxal treatment groups. The majority of the other drop outs were due to either withdrawal of consent or "lost to follow-up". There were 188 patients in the modified intent-to-treat group ("MITT") consisting of all randomized patients with at least one efficacy evaluation.

The proportion of men in the 12.5mg and 25mg treatment arms with total testosterone in the physiological range at month three using the last observation carried forward was 72.7% and 79.2%, respectively, and those on Androgel and placebo the proportion was 57.4% and 28.3%, respectively. These results confirm non-inferiority to Androge
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