BioCentury
ARTICLE | Clinical News

Enclomiphene citrate: Interim Phase II data

September 5, 2016 7:00 AM UTC

Interim data from the double-blind, U.S. Phase II ZA-205 trial in about 50 obese male patients with hypogonadotropic hypogonadism and morning testosterone levels of <=300 ng/dL showed that enclomiphene significantly increased total testosterone and free testosterone levels from baseline to 6 months vs. placebo (p=0.0017 and p=0.002, respectively). Specifically, enclomiphene increased mean total testosterone levels from 277.3 ng/dL at baseline to 780.9 ng/dL at 6 months and increased free testosterone levels from 56.3 pg/mL at baseline to 140.1 pg/mL at 6 months. Placebo increased mean total testosterone levels from 263.9 ng/dL at baseline to 368.2 ng/dL at 6 months and increased free testosterone levels from 55.6 pg/mL at baseline to 57.1 pg/mL at 6 months. Additionally, 88% of patients treated with enclomiphene achieved testosterone levels in the normal range after 6 months vs. 23% of patients treated with placebo. Furthermore, enclomiphene increased mean lean body mass by 1.4 kg vs. a decrease of 0.3 kg for placebo. ...