Status: Currently recruiting participants.
Purpose:
To determine if Androxal® can reverse the suppression of the hypothalamic-pituitary axis and secretion of pituitary 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.
Eligibility:
Males, ages 21 years to 60 years
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 with any clinically significant medical condition other than AIHH, medication or drug use rendering the subjects infertile or marginally fertile.
- Current or history of prostate cancer or a suspicion of prostate disease unless ruled out by prostate biopsy, or a PSA>3.6.
Study Drug:
Androxal® 25mg and Testim® 1% gel
Study Design:
Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measures:
Change in semen volume, sperm count and sperm motility from baseline in men treated with Androxal® versus men treated with Testim®
Secondary Outcome Measures:
Change serum LH, FSH and total testosterone in Androxal® versus Testim®-treated men
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Study Director:
Ronald Wiehle, Ph.D.
Repros Therapeutics Inc.
281-719-3400
If you meet the study criteria and are interested in participating in the study, please contact:
Current Clinical Site Locations:
For more information, please visit www.clinicaltrials.gov
Locations
New York, New York 10016
Purchase, New York 10577
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