CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02651688
NCT02651688Phase 2Completed

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

Repros Therapeutics Inc.·interventional·Posted Jan 11, 2016·Updated Jun 27, 2019

In Brief

A Phase 2 clinical trial evaluating Placebo and Enclomiphene for Acquired Hypogonadotropic Hypogonadism and Obesity. Completed, enrolled 50 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 11, 2016
Enrollment StartJan 11, 2016
Primary CompletionMay 2, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 10.5 years ago

Interventions

Placebodrug

One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.

Enclomiphenedrug

Enclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.