NCT01739582

An Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

An Open Label, 6 Month Phase III Extension Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety profile of Androxal in men with secondary hypogonadism.

Detailed description

This study is an open-label, multi-center Phase 3 extension study to evaluate the safety on continued treatment with Androxal in subjects who completed either ZA-301 or ZA-302. The study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. Subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. At Visit 2 (Week 6) subjects who do not achieve morning T values ≥450 ng/dL will be up-titrated to 25 mg. Safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-12-03
• Last updated: 2014-04-16