Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
- Conditions
- Secondary Hypogonadism
- Interventions
- Registration Number
- NCT00962637
- Lead Sponsor
- Repros Therapeutics Inc.
- 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 in men with secondary hypogonadism. Subjects were randomly assigned to 1 of 4 treatments groups. Appropriate amounts of medications were dispensed at each visit. Subjects took their medications orally or by rubbing it onto the skin (depending on the treatment assignment) once daily for up to 6 months. Treatment visits occurred at approximately 4-week intervals for Months 1, 2, and 3 and then at 6-week intervals for Months 4, 5, and 6.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 194
- Total serum testosterone concentrations < 300 ng/dL at baseline
- Presence or history of prostate cancer
- Elevated PSA > 3.5 ng/mL
Additional inclusion and exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo Placebo 1 Androxal Androxal™ 12.5 mg 2 Androxal Androxal™ 25 mg 3 AndroGel AndroGel®
- Primary Outcome Measures
Name Time Method Evaluate the safety of Androxal™ administered in men with secondary hypogonadism Six months
- Secondary Outcome Measures
Name Time Method Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel® Six months
Trial Locations
- Locations (18)
Northeast Indiana Research, LLC
🇺🇸Fort Wayne, Indiana, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Southeastern Research Group, Inc.
🇺🇸Tallahassee, Florida, United States
Office of Stephen Miller, MD
🇺🇸Las Vegas, Nevada, United States
Office of Michael Mall, MD
🇺🇸Las Vegas, Nevada, United States
Office of Keith Pierce, MD
🇺🇸Livonia, Michigan, United States
Advanced Biomedical Research, Inc.
🇺🇸Hackensack, New Jersey, United States
Office of Gary S. Karlin
🇺🇸Lawrenceville, New Jersey, United States
Medial Research Associates of Nashville
🇺🇸Nashville, Tennessee, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham,, Alabama, United States
Prime-Care Clinical Research
🇺🇸Mission Viejo, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Medical Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Commonwealth Biomedical Research
🇺🇸Madisonville, Kentucky, United States
Northern California Research Corp.
🇺🇸Carmichael, California, United States
The Center for Sexual Medicine at Sheppard Pratt
🇺🇸Baltimore, Maryland, United States
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States