A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal [enclomifene] to a Topical Testosterone [Testim] in Men Previously Treated With Topical Testosterone.

Trial Profile

A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal [enclomifene] to a Topical Testosterone [Testim] in Men Previously Treated With Topical Testosterone.

Completed
Phase of Trial: Phase II

Latest Information Update: 24 Aug 2015

At a glance

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

    • 10 Apr 2013 Results assessing the effects of treatment on levels of IGF-1 and hormones presented at the 104th Annual Meeting of the American Association for Cancer Research.
    • 10 Nov 2010 In preparation for phase 3 trials, the FDA opined that this phase 2B study would provide for a more solid database for design and eventual approval of such studies under an SPA, according to a Repros Therapeutics media release.
    • 14 Aug 2009 Actual end date (Aug 2009) added as reported by ClinicalTrials.gov.
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