drugset / Trial / NCT01739595

Phase III Study to Evaluate Morning Testosterone Normalization in Overweight Men With Secondary Hypogonadism

NCT01739595

Phase 3 Completed 181 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of ZA-302 is to determine the effects of Androxal on morning testosterone and reproductive status in younger overweight men with acquired hypogonadotropic hypogonadism (confirmed morning T\<300 ng/dL) and normal sperm concentration, compared to changes with placebo. Subjects must not have previously been treated with testosterone products within the last 6 months.

Timeline

Start
2012-11
Primary completion
2013-09
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Androxal Unknown 12.5 mg Oral
Subject Androxal Unknown 25 mg Oral