NCT00706719

To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone

A Randomized, Open-Label, Fixed Dose, Active-Control, Multi-Center Phase IIB Study to Evaluate Fertility in Men With Secondary Hypogonadism, Comparing Androxal® to a Topical Testosterone in Men Previously Treated With Topical Testosterone.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 21 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone.

Detailed description

The study was designed to determine if Androxal® would affect sperm parameters (count, concentration, volume) in men with secondary hypogonadism who have been previously treated with topical testosterone. A maximum of twelve subjects per group were randomized to daily treatments of Androxal® or topical testosterone (Testim®) for six months. The protocol was later amended to include a treatment group who received Androxal after a 3 month wash out period.

Conditions

• Secondary Hypogonadism

Interventions

Type	Name	Description
DRUG	25 mg Androxal	25 mg Androxal capsules, 1 capsule daily for 6 months
DRUG	Testim 1%	Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2008-06-27
• Last updated: 2015-08-19
• Results posted: 2010-10-08

Locations

2 sites across 1 country: United States