NCT01386606

The Effect on Androxal Versus Androgel on Morning Testosterone in Men With Secondary Hypogonadism (Low Testosterone)

A Randomized, Single Blind, Multi-Center Phase II Study to Evaluate the Effect of Three Different Doses of Androxal and AndroGel on 24-Hour Luteinizing Hormone and Testosterone in Normal Healthy Men

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (\<350 ng/dL)after 6 weeks of continuous dosing.

Detailed description

Study will require 7 visits, which includes 2 overnight stays in a clinic. One visit is an eye exam. Blood samples are required at all visits including sampling every hour for a 24 hour time period during the 2 overnight stays. A six month extension study will be available for all subjects completing the 6-week study.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	Androxal (enclomiphene citrate)	capsule oral 1X a day 6 weeks
DRUG	Testosterone	topical gel 1X a day 6 weeks

Timeline

• Start date: 2011-06-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2011-07-01
• Last updated: 2015-09-23
• Results posted: 2015-09-23

Locations

2 sites across 1 country: United States