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

Secondary Hypogonadism Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00706719
• Other study ID #: ZA-201
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2008
• Last updated: July 22, 2015
• Start date: June 2008
• Est. completion date: August 2009

Study information

• Verified date: July 2015
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypogonadism
• Neoplasm Metastasis
• Secondary Hypogonadism

Intervention

Drug:
• 25 mg Androxal
25 mg Androxal capsules, 1 capsule daily for 6 months
• Testim 1%
Testim 1% gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Locations

Country	Name	City	State
United States	University Urology Associates	New York	New York
United States	MAZE Labs	Purchase	New York

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm Concentration	Total sperm concentration was measured.	Baseline, Month 3, Month 6, Follow-Up (Month 7)	No
Primary	Motile Total Sperm Count	Motile total sperm count was measured.	Baseline, Month 3, Month 6, Follow-Up (Month 7)	No
Primary	Semen Volume	Semen volume was measured.	Baseline, Month 3, Month 6, Follow-Up (Month 7)	No
Secondary	Luteinizing Hormone (LH) Levels	LH levels were measured.	Baseline, Month 3, Month 6, Follow-Up (Month 7)	No
Secondary	Follicle Stimulating Hormone (FSH) Levels	FSH levels were measured.	Baseline, Month 3, Month 6, Follow-Up (Month 7)	No