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
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
Outcome
Mixed primary results
registry MEAN Enclomiphene 12.5 mg: Change from Baseline to week 48: 173.81 (Standard Deviation 130.7) ng/dL NCT02651688 ↗
registry MEAN Placebo: Change from Baseline to week 48: 43.33 (Standard Deviation 59.50) ng/dL NCT02651688 ↗
registry analysis (superiority test); Enclomiphene 12.5 mg vs Placebo; p = 0.0034; Wilcoxon rank-sum test NCT02651688 ↗
registry MEAN Enclomiphene 12.5 mg: Change from Baseline to Week 48: -4.36 (Standard Deviation 9.95) kg NCT02651688 ↗
registry MEAN Placebo: Change from Baseline to Week 48: -14.51 (Standard Deviation 10.34) kg NCT02651688 ↗
registry analysis (superiority test); Enclomiphene 12.5 mg vs Placebo; p = 0.0139; Wilcoxon rank-sum test NCT02651688 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Androxal | Unknown | 12.5 mg | Oral |
| Subject | Androxal | Unknown | 25 mg | Oral |