Repros Therapeutics Inc. (RPRX) Release: FDA Recommends Sperm Endpoints As Key Parameters For Assessment Of Androxal® Versus Approved Topical Gel
4/30/2014 5:15:02 PM
THE WOODLANDS, Texas, April 30, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it has received guidance from the Food and Drug Administration (FDA) regarding primary endpoints for the two studies, ZA-304 and ZA-305, that Repros is currently conducting of Androxal® against a leading approved testosterone gel. The FDA stated that sperm concentration reductions should take into consideration recognized thresholds for fertility treatments, and also that the clinical significance of the degree of sperm concentration decline between the beginning and end of the treatment period is important, as it may represent an adverse effect on fertility, even if sperm concentration stays in the normal range.
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