NCT01993225

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 12.5 mg or 25 mg Androxal or AndroGel 1.62%.

Conditions

• Secondary Hypogonadism

Interventions

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

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2013-11-25
• Last updated: 2014-10-01

Locations

9 sites across 1 country: United States