NCT01993212

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: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This is 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 the 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal 12.5 mg or 25 mg
DRUG	AndroGel 1.62%
DRUG	Placebo Capsules
DRUG	Placebo Gel

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2013-11-25
• Last updated: 2014-10-01

Locations

8 sites across 1 country: United States