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

Phase 2

Completed

• Conditions: Secondary Hypogonadism
• Interventions: Drug: 25 mg Androxal; Drug: Testim 1%

• Registration Number: NCT00706719
• Lead Sponsor: Repros Therapeutics Inc.

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-25
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-27
• Primary Completion: 2009-07
• Study Completion: 2009-08
• Results First Submitted: 2010-08-25
• Results First Submitted QC: 2010-09-21
• Results First Posted: 2010-10-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-22
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

Inclusion Criteria

• Healthy adult males between 21 and 60 years of age who have been diagnosed with AIHH.
• Subjects must have been treated with a topical testosterone replacement therapy (typically AndroGel® or Testim®) for at least 6 months at enrollment and for not more than 2 years.

Exclusion Criteria

• A history of idiopathic infertility due to primary hypogonadism, testicular failure, Kallmann's syndrome or any other infertility condition.
• Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile other than AIHH.
• Men with a history of, known, or suspected prostate disease not ruled out by a prostate biopsy, or a prostate specific antigen (PSA)>3.6 or clinical suspicion of current prostate disease.
• Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 mg Androxal no wash out	25 mg Androxal	1 capsule daily for 6 months of 25 mg of Androxal in men without a 3 month wash out period
25 mg Androxal wash out	25 mg Androxal	1 x 25 mg Androxal capsule daily for 6 months in men with a previous 3 month washout period of topical testosterone
Testim 1% (topical testosterone)	Testim 1%	Testim 1% Gel applied topically for 6 months

Primary Outcome Measures

Name	Time	Method
Motile Total Sperm Count	Baseline, Month 3, Month 6, Follow-Up (Month 7)	Motile total sperm count was measured.
Sperm Concentration	Baseline, Month 3, Month 6, Follow-Up (Month 7)	Total sperm concentration was measured.
Semen Volume	Baseline, Month 3, Month 6, Follow-Up (Month 7)	Semen volume was measured.

Secondary Outcome Measures

Name	Time	Method
Luteinizing Hormone (LH) Levels	Baseline, Month 3, Month 6, Follow-Up (Month 7)	LH levels were measured.
Follicle Stimulating Hormone (FSH) Levels	Baseline, Month 3, Month 6, Follow-Up (Month 7)	FSH levels were measured.

Trial Locations

Locations (2)

University Urology Associates; 🇺🇸 New York, New York, United States

MAZE Labs; 🇺🇸 Purchase, New York, United States