Status:
COMPLETED
Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Secondary Hypogonadism
Eligibility:
MALE
18-68 years
Phase:
PHASE3
Brief Summary
Approximately 4 to 5 million men in the U.S. are testosterone-deficient. Enclomiphene (trans-clomiphene) citrate (Androxal) was evaluated to determine if Androxal increased serum testosterone levels i...
Eligibility Criteria
Inclusion
- Total serum testosterone concentrations \< 300 ng/dL at baseline
Exclusion
- Presence or history of prostate cancer
- Elevated PSA \> 3.5 ng/mL
- Additional inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT00962637
Start Date
March 1 2006
End Date
May 1 2007
Last Update
February 11 2010
Active Locations (18)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States, 35801
3
Northern California Research Corp.
Carmichael, California, United States, 95608
4
Prime-Care Clinical Research
Mission Viejo, California, United States, 92691