Androxal enclomiphene: Phase III data
Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-305 trial in 117 evaluable men with secondary hypogonadism showed that Androxal was superior to AndroGel 1.62% testosterone gel on the co-primary endpoints of the proportion of patients who achieved a 24-hour average testosterone level in the normal range with a mean sperm concentration of >=10 million/mL and in percent change from baseline in sperm concentration at week 16. Specifically, 65.9% of patients receiving Androxal achieved a 24-hour average testosterone level in the normal range with a mean sperm concentration of >=10 million/mL vs. 33.3% for AndroGel (p=0.0047) and 7.3% for placebo (p<0.0001). Androxal led to a 14% increase in mean sperm concentration from baseline to week 16 vs. a reduction of 30% for AndroGel (p=0.0004) and an increase of 7% for placebo (p=0.2042). ...