NCT01534208

Safety Study of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

An Open Label, Escalating Dose, 6 Month Phase III Safety Study Of Enclomiphene Citrate in the Treatment of Men With Secondary Hypogonadism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 499 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Detailed description

This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal	Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Timeline

• Start date: 2012-05-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-02-16
• Last updated: 2014-07-24
• Results posted: 2014-07-24

Locations

31 sites across 1 country: United States