drugset / Trial / NCT02651688

A Multi-Center Study in Men With Acquired Hypogonadotropic Hypogonadism to Compare Changes in Body Composition and Metabolic Parameters With Diet and Exercise in Conjunction With Treatment With 12.5 mg or 25 mg Enclomiphene

NCT02651688

Phase 2 Completed 50 enrolled Repros Therapeutics Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the effects of 12 months of treatment with enclomiphene 12.5 mg, 25 mg, or placebo capsules on body composition and metabolic parameters in overweight men with acquired hypogonadotropic hypogonadism \[confirmed morning testosterone (T) ≤300 ng/dL\] following a 6 month diet and 15 month exercise program.

Timeline

Start
2016-01-11
Primary completion
2017-05-02
Completion
2017-05-02

Drugs

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