A One Year Open Label Study for the Treatment of Hypogonadism (Low Testosterone) in Men Who Have Completed ZA-203

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to determine the continued effects of Androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol ZA-203. Men will be allowed to choose Androxal (enclomiphene citrate) or Testim (topical testosterone) at the beginning of the study. All men on Androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.

• Phase: Phase 2
• 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:

• Successful completion of ZA-203

• Ability to understand and provide written informed consent

• Agreement to use a condom, and with a fertile female partner, another form of contraception

• Agreement to provide semen samples in the clinic

Exclusion Criteria:

• Any condition which, in the opinion of the Investigator, would make the Subject an unsuitable candidate for enrollment in the study