FDA Confirms Endpoints of Androxal Study

Repros Therapeutics Inc.®

today announced it has received additional guidance from the FDA regarding primary endpoints for the two studies, ZA-304 and ZA-305, that it is currently conducting comparing Androxal® to the leading approved testosterone gel and placebo. The FDA proposed three co-primary endpoints: Percentage change from baseline in sperm concentration comparing Androxal® to the leading U.S. testosterone replacement therapy; Proportion of men obtaining a testosterone in the normal range; and Percentage of men that exhibit sperm ≥ 10 million/mL at the end of 16 weeks of dosing and testosterone in the normal range, comparing Androxal® to a testosterone gel as well as comparing Androxal® to placebo. The primary endpoints and statistical analysis plan outlined for ZA-304 and ZA-305 below are being modified to comply with the FDA suggestions. The Company believes the two studies are adequately powered to meet these endpoints.