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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%

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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%

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Nov 2021

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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 + ZA-305) published in the BJU International
  • 01 Apr 2015 According to a Repros Therapeutics media release, a New Drug Application for Enclomiphene Citrate developed for the treatment of secondary hypogonadism in overweight men wishing to restore normal testicular function has been accepted for review by the US FDA.

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