- Enrollment in 6 Month Open Label Study Near Completion
- FDA Meeting Request Submitted
- Joachim F. Wernicke, Ph.D, M.D., Named Chief Medical Officer
- Company to Present at BIO CEO in NYC February 11, 2013
THE WOODLANDS, Texas, Feb. 11, 2013 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today provided an update for both of its core clinical programs.
Androxal ® Six Month Open Label Study (ZA-300)
As part of the FDA requirement for total number of subjects to be exposed for six months, the Company is conducting a 500 subject open label study. To date, the Company has enrolled 499 subjects and expects the study to be fully enrolled this week.Androxal ® Pivotal Studies (ZA-301 and ZA-302) The Company has sent a "request for guidance" letter to the FDA. The key points were:
- The identification of a single high enrolling site with a population whose baseline characteristics appear different from the other sites;
- The Company has proposed enrolling an additional 40 subjects into each of the two pivotal studies to allow for subset analysis while retaining the power of the original protocols;
- The Company proposed moving two sites from the enrolling study ZA-302 to the closed for enrollment study ZA-301.
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