NCT01270841

Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

A Randomized, Double Blind, Placebo and Active Controlled, Parallel, Multi-Center Phase IIb Study to Evaluate Normalization of Morning Testosterone Levels in Men With Secondary Hypogonadism

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The Purpose of the study is to determine the effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism(confirmed morning Testosterone less than 250 ng/dL), compared to changes with placebo, or Testim (topical testosterone). The effects of Testim versus placebo on reproductive status will also be examined. Study subjects must not be currently using a topical testosterone.

Detailed description

This study is a phase IIb, 4 arm study with three month active dosing period. Three of the four treatment groups will be randomized to either Androxal or placebo in a double-blind fashion, and the fourth treatment group will receive open-label Testim. The doses of Androxal in the blinded portion of the study will be 12.5 mg and 25 mg, in capsule form.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsule 1x daily for 3 months
DRUG	topical testosterone	testosterone gel applied 1x daily for 3 months
DRUG	Androxal	Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-01-05
• Last updated: 2014-07-28
• Results posted: 2014-07-28

Locations

18 sites across 1 country: United States