A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

Trial Profile

A Randomized, Double Blind, Placebo-Controlled, Multi-Center Phase III Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Testosterone and Sperm Concentration Following Treatment With 12.5 mg or 25 mg Androxal or AndroGel 1.62%

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2016

At a glance

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

    • 04 Apr 2016 Results assessing diurnal variation of testosterone secretion from four studies presented at The 98th Annual Meeting of the Endocrine Society
    • 23 Oct 2015 Pooled results (ZA-304 + 305) published in the BJU International
    • 01 Apr 2015 According to a Repros Therapeutics media release, US FDA accepted the New Drug Application for Enclomiphene Citrate developed for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function.
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