Repros Therapeutics Inc. ® (NasdaqCM:RPRX) today reported it has submitted to the FDA a reanalysis of the previously completed 200 subject trial ZA-003 of Androxal ® in the treatment of secondary hypogonadism as noted by Repros in the Company’s press release of November 9, 2010. The Company contracted an outside statistician, Tony Orlando, Ph.D., V.P., Global Data Division, Pharm-Olam International Ltd., to conduct the analysis.
Dr. Orlando performed several different analyses. He first assessed the subset of men in the 003 study that exhibited morning testosterone levels ≤ 250 ng/dl to mimic the upcoming Phase IIb study. He examined the data for the men after three months of treatment and again for those that completed the six month study. There were 11, 16, 20 and 21 men in the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups, respectively, that met the baseline testosterone criteria and completed three months of the study. After three months of treatment the mean change from baseline in morning testosterone levels for the four groups were 216.8, 260.5, 213.6 and 50.1 ng/dl for the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups, respectively. Even with the small number of men in this subset, both doses of Androxal achieved statistically significant changes from baseline results when compared to placebo (p=0.0001 @ 25 mg and 0.0021 @ 12.5 mg). For the men from this group that remained in the study for the full six month period, changes from baseline levels as compared to placebo remained significant (p<0.01).
Dr. Orlando also performed a “completer” analysis for all the men in the study. Now with roughly 33 to 37 men per group, he observed that mean changes of morning testosterone for the four groups from baseline to after six months of treatment were 139.4, 271.5, 132.3 and 12.5 ng/dl for the 12.5 mg Androxal, 25 mg Androxal, Androgel and placebo groups respectively. Both of the Androxal groups exhibited p values < 0.0001 compared to placebo. Mean testosterone levels after the six month study were 410.4 at 12.5 mg and 519.3 at 25 mg Androxal.