Enclomiphene: Additional Phase III data

Data from 317 men <60 years of age with a BMI of >25 in the single-blind, U.S. Phase III DEXA (ZA-303) trial showed no evidence of a negative effect on BMD as assessed by dual x-ray absorptiometry (DEXA) scans in patients who received Androxal compared to placebo. Androxal led to an increase in mean total hip BMD from baseline to 12 months of 0.01% vs. a reduction of 0.63% for placebo (p=0.0043). Androxal led to a mean reduction in spine BMD from baseline to 12 months of 0.34% vs. an increase of 0.02% for placebo (p=0.3905). Androxal led to a mean increase in femoral neck BMD from baseline to 12 months of 0.02% vs. a reduction of 0.33% for placebo (p=0.2671). Additionally, the proportion of Androxal-treated patients achieving morning testosterone levels of >=300 ng/dL was 79.3% over the 12-month treatment period and 71.4% using a last observation carried forward (LOCF) analysis. Repros previously reported interim 6-month data (see BioCentury, Sept. 2, 2013). ...