Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
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.