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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism.

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Trial Profile

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Nov 2021

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At a glance

  • Drugs Enclomifene (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Therapeutic Use
  • Sponsors Repros Therapeutics

    • Most Recent Events

    • 29 Dec 2010 A reanalysis of trial data by an independent statistician has shown emclomifene provides significant improvement in testosterone levels in men with testosterone levels of less than or equal to 250 ng/dL, according to a Repros Therapeutics media release.
    • 10 Nov 2010 In preparation for phase 3 trials, Repros Therapeutics agreed with Type B meeting FDA comments and will analyse the ZA-003 study for the subset of men with morning testosterone less than 250 ng/dl and submit data.
    • 18 Aug 2010 Repros Therapeutics has requested a Type B Meeting with the FDA to review the company's phase III protocols for Androxal in the treatment of secondary hypogonadism, according to a Repros Therapeutics media release.

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