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

A Randomized, Double Blind, Placebo-Controlled, 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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 T≤300 ng/dL) following a 6 month diet and 15 month exercise program. Participants must not have been treated with testosterone products in the 6 months prior to the study and must not ever have used testosterone products for a year or longer.

Conditions

• Acquired Hypogonadotropic Hypogonadism
• Obesity

Interventions

Type	Name	Description
DRUG	Placebo	One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.
DRUG	Enclomiphene	Enclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.

Timeline

• Start date: 2016-01-11
• Primary completion: 2017-05-02
• Completion: 2017-05-02
• First posted: 2016-01-11
• Last updated: 2019-06-27
• Results posted: 2019-06-14

Locations

5 sites across 1 country: United States