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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
194
12.5 mg once daily
25 mg once daily
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.
1 capsule daily
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
...and 8 more locations
Evaluate the safety of Androxal™ administered in men with secondary hypogonadism
Time frame: Six months
Demonstrate that treatment of men with secondary hypogonadism with Androxal™ was non-inferior to treatment with the active control, AndroGel®
Time frame: Six months
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