Status:
COMPLETED
To Evaluate Sperm Parameters in Men With Secondary Hypogonadism Previously Treated With Topical Testosterone
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Secondary Hypogonadism
Eligibility:
MALE
21-60 years
Phase:
PHASE2
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 testoster...
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 testoster...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00706719
Start Date
June 1 2008
End Date
August 1 2009
Last Update
August 19 2015
Active Locations (2)
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1
University Urology Associates
New York, New York, United States, 10016
2
MAZE Labs
Purchase, New York, United States, 10577