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

Completed · Phase 2

Conditions studied: Secondary Hypogonadism

In brief

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.

Key facts

Study ID

NCT00706719

Run by

Repros Therapeutics Inc.

People needed

17

Starts

2008-06-01

Expected to finish

2009-08-01

Last updated by the study team

2015-08-19

Who can join

Age: 21 and older, up to 60. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University Urology Associates — New York, New York, United States
• MAZE Labs — Purchase, New York, United States

Full record on ClinicalTrials.gov

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