A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration.

Trial Profile

A Randomized, Double Blind, Placebo Controlled Multi-Center Phase III Study to Evaluate Normalization of Morning Testosterone Levels in Overweight Men With Acquired Hypogonadotropic Hypogonadism and Normal Sperm Concentration.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2016

At a glance

  • Drugs Enclomifene (Primary)
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • 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
    • 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.
    • 02 Feb 2015 Data from this trial supported an NDA submission to the US FDA for enclomifene in the treatment of secondary hypogonadism in overweight men, according to a Repros Therapeutics media release.
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