drugset / Trial / NCT01532414

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

NCT01532414

Phase 3 Completed 151 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of ZA-301 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
2012-08
Primary completion
2013-03
Completion
2013-03

Drugs

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