194
Participants
Start Date
March 31, 2006
Primary Completion Date
May 31, 2007
Study Completion Date
May 31, 2007
Androxal
12.5 mg once daily
Androxal
25 mg once daily
AndroGel
5 g applied topically daily. The subject was to return to the clinic every 2 weeks for the first 2 months to monitor serum testosterone levels. If testosterone concentration remained below the normal level, the dose of AndroGel® could have been increased to 10 g and then to 15 g according to the guidance provided in the product package insert.
Placebo
1 capsule daily
The Center for Sexual Medicine at Sheppard Pratt, Baltimore
Southeastern Research Group, Inc., Tallahassee
Alabama Clinical Therapeutics, LLC, Birmingham
Medical Affiliated Research Center, Inc., Huntsville
Medial Research Associates of Nashville, Nashville
Commonwealth Biomedical Research, Madisonville
Northeast Indiana Research, LLC, Fort Wayne
Office of Keith Pierce, MD, Livonia
Urology San Antonio Research, PA, San Antonio
Salt Lake Research, Salt Lake City
Office of Michael Mall, MD, Las Vegas
Office of Stephen Miller, MD, Las Vegas
Harbor-UCLA Medical Center, Torrance
Prime-Care Clinical Research, Mission Viejo
Northern California Research Corp., Carmichael
Chase Medical Research, LLC, Waterbury
Advanced Biomedical Research, Inc., Hackensack
Office of Gary S. Karlin, Lawrenceville
Repros Therapeutics Inc.
INDUSTRY