Androxal enclomiphene: Phase IIb data

Top-line data from the double-blind, U.S. Phase IIb ZA-203 trial in 108 men less than 65 years of age who were naïve to testosterone therapy and who had morning testosterone levels of <250 ng/dL showed that once-daily 12.5 and 25 mg Androxal significantly increased median morning testosterone levels from baseline to 3 months vs. placebo. Specifically, low- and high-dose Androxal increased median morning testosterone levels from 202 ng/dL at baseline for both doses to 433 and 415 ng/dL, respectively, at 3 months, whereas placebo reduced median morning testosterone levels from 220 ng/dL at baseline to 196 ng/dL at 3 months (p<0.0001 for both). The active control topical Testim testosterone also significantly increased median morning testosterone levels from 207 ng/dL at baseline to 393 ng/dL at 3 months vs. placebo (p=0.0002). There were no significant differences between active treatment arms in testosterone levels. ...