Spots Global Cancer Trial Database for Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
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Trial Identification
Brief Title: Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Open-Label, Active-Controlled Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Study ID: NCT00962637
Conditions
Study Description
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:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Alabama Clinical Therapeutics, LLC, Birmingham,, Alabama, United States
Medical Affiliated Research Center, Inc., Huntsville, Alabama, United States
Northern California Research Corp., Carmichael, California, United States
Prime-Care Clinical Research, Mission Viejo, California, United States
Harbor-UCLA Medical Center, Torrance, California, United States
Chase Medical Research, LLC, Waterbury, Connecticut, United States
Southeastern Research Group, Inc., Tallahassee, Florida, United States
Northeast Indiana Research, LLC, Fort Wayne, Indiana, United States
Commonwealth Biomedical Research, Madisonville, Kentucky, United States
The Center for Sexual Medicine at Sheppard Pratt, Baltimore, Maryland, United States
Office of Keith Pierce, MD, Livonia, Michigan, United States
Office of Michael Mall, MD, Las Vegas, Nevada, United States
Office of Stephen Miller, MD, Las Vegas, Nevada, 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
Urology San Antonio Research, PA, San Antonio, Texas, United States
Salt Lake Research, Salt Lake City, Utah, United States
Contact Details
Name: Andre van As, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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