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.”

To determine if Androxal® can correct the central defect in men who have AIHH that blocks their ability to produce the hormones (LH and FSH) which stimulate testosterone production and sertoli cell number, thereby restoring sperm count. Twelve subjects per group will be randomized to daily treatments of Androxal® or topical testosterone Testim ® for six months.

These men must have been previously treated with exogenous testosterone.

Study Type: Interventional

Study Design: Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2009

Intervention(s) in this Clinical Trial

• Drug: enclomiphene citrate
  • capsules, 25 mg, 1 capsule daily for 6 months
• Drug: topical testosterone gel
  • gel, dosage to be titrated according to manufacturer's instructions, once daily for 6 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • 1 capsule daily of 25 mg of Androxal®
• Active Comparator: B
  • Testim® 1% Gel

Primary Measures

• Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal®
  • Time Frame: Months 3 and 6
    Safety Issue?: No

Secondary Measures

• Change in semen volume, sperm count and sperm motility in men treated with Androxal® versus men treated with Testim®
  • Time Frame: Months 3 and 6.
    Safety Issue?: No

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 PSA>3.6 or clinical suspicion of current prostate disease.
• Men with a hematocrit in excess of 50 % or hemoglobin >17 g/dl

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Repros Therapeutics Inc.

Overall Clinical Trial Officials and Contacts

Ronald Wiehle, PhD Study Director Repros Therapeutics Inc.  

Overall Contact: Ronald Wiehle, PhD 281-719-3400 administrator@reprosrx.com

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00706719

Study ID Number: ZA-201

ClinicalTrials.gov Identifier: NCT00706719

Health Authority: United States: Food and Drug Administration