Androxal superior to Androgel in Phase 3 trial

Recommended by Dr. Michael White, Updated on October 25th, 2018

Shares of Repros Therapeutics (NASDAQ:RPRX) are up12%premarket on good volume in response to its report of positive results for oralAndroxal (clomiphene citrate) (NYSE:ABBV) versus topical Androgel (testosterone gel) in a Phase 3 trial. In the study, ZA-304, Androxal met its co-primary efficacy endpoints while demonstrating results consistent with an earlier trial. Androxal was superior to Androgel in the percent change from baseline in average sperm concentration and percent of subjects considered to be responders. A responder is defined as a person achieving a 24-hour average testosterone in the normal range with associated average sperm concentration of 10 million/mL. The 129-patient study group was randomized into three cohorts, Androxal (41), Androgel (43) and placebo (45). The first primary efficacy endpoint was the percent change from baseline in sperm concentration. The median decrease in the Androxal cohort was 1% (stated as unchanged) compared to a median decrease of 71% in the Androgel cohort. The results were statistically significant compared to baseline and Androgel. The second primary efficacy endpoint was a comparison of the proportion of responders. The Androxal cohort demonstrated a success rate of 61% (25/41) compared to 16% (7/43) for Androgel. Again, the results were statistically significant. The company has a pre-IND meeting scheduled with the FDA for mid-November. It expects to file by year end. If approved, it will be the first drug therapy specifically targeting secondary hypogonadism. Share this with a colleague

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Androxal superior to Androgel in Phase 3 trial

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