Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism
- Registration Number
- NCT01067365
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.
- Detailed Description
The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 104
- 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 12.5 mg Androxal Androxal 12.5 mg Androxal daily 25 mg Androxal Androxal 25 mg Androxal daily
- Primary Outcome Measures
Name Time Method Evaluate the safety of Androxal™ administered in men with secondary hypogonadism One year
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Office of Stephen Miller, MD
🇺🇸Las Vegas, Nevada, United States
Northern California Research Corp
🇺🇸Carmichael, California, United States
Harbor-UCLA Medical Center
🇺🇸Torrance, California, United States
Salt Lake Research
🇺🇸Salt Lake City, Utah, United States
Medial Affiliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Office of Gary S. Karlin, MD
🇺🇸Lawrenceville, New Jersey, United States
Urology San Antonio Research, PA
🇺🇸San Antonio, Texas, United States
Alabama Clinical Therapeutics, LLC
🇺🇸Birmingham,, Alabama, United States
Prime-Care Clinical Research
🇺🇸Mission Viejo, California, United States
Southeastern Research Group, Inc.
🇺🇸Tallahassee,, Florida, United States
Northeast Indiana Research, LLC
🇺🇸Fort Wayne, Indiana, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Commonweatlh Biomedical Research
🇺🇸Madisonville,, Kentucky, United States
The Center for Sexual Medicine at Sheppard Pratt
🇺🇸Baltimore, Maryland, United States
Advanced Biomedical Research, Inc.
🇺🇸Hackensack, New Jersey, United States
Medical Research Associates of Nashville
🇺🇸Nashville, Tennessee, United States
Office of Keith Pierce, MD
🇺🇸Livonia, Michigan, United States
Office of Michael Mall, MD
🇺🇸Las Vegas, Nevada, United States