In the Company’s submission that reanalyzed the data from previous studies of Androxal, it also reviewed with the FDA the variability of morning testosterone levels from day to day. Over a six-month period, men on placebo moved in and out of the normal range for morning testosterone. In that submission the Company noted, “The sponsor believes this finding raises one other consideration. Given that a variety of factors can cause episodes of low testosterone, we believe starting all men on exogenous testosterone is not appropriate. Once exogenous testosterone therapy is initiated a subject would be relegated to such therapy due to the suppressive effects on pituitary responsiveness. A drug such as Androxal would allow men who exhibit episodes of low T to be treated in a fashion that does not impair pituitary responsiveness. This is particularly true for younger men. As the male ages and the testes no longer are capable of responding to pituitary stimulatory signals, exogenous preparations of testosterone would be appropriate treatments.”About Repros Therapeutics Inc.
Repros Therapeutics® Receives IRB Approval To Commence Phase IIb Study Of Androxal® In The Treatment Of Secondary Hypogonadism
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