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ARTICLE | Clinical News

Enclomiphene: Phase III data

September 29, 2014 7:00 AM UTC

Top-line data from the double-blind, double-dummy, U.S. Phase III ZA-304 trial in 114 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, 61% 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. 16.3% for AndroGel and 4.4% for placebo (p<0.0001 for both). Androxal led to an 11% increase in mean sperm concentration from baseline to week 16 vs. a reduction of 53% for AndroGel (p<0.0001) and an increase of 4% for placebo (p=0.558). The trial enrolled men with sperm counts in the normal range at baseline (>15 million/mL) on 2 separate days separated by >=2 days and with a morning testosterone level of <300 ng/dL on both of those days. ...