drugset / Trial / NCT01386567

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

NCT01386567

Phase 2 Completed 48 enrolled Repros Therapeutics Inc.
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2011-07
Primary completion
2013-01
Completion
2013-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 25 mg Oral
Comparator Testosterone Small molecule Topical

Indications