NCT01067365

Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

Detailed description

The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal	12.5 mg once daily
DRUG	Androxal	25 mg once daily

Timeline

• Start date: 2006-03-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2010-02-11
• Last updated: 2014-06-27

Locations

18 sites across 1 country: United States