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: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.
• Treatments: Citric Acid; Clomiphene; Enclomiphene; Methyltestosterone; Sodium Citrate; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate; Zuclomiphene

Criteria

Inclusion Criteria:

• Total serum testosterone concentrations < 300 ng/dL at baseline

Exclusion Criteria:

• Presence or history of prostate cancer

• Elevated PSA > 3.5 ng/mL

Additional inclusion and exclusion criteria may apply.