drugset / Trial / NCT03047330
Menopausal Sleep Fragmentation and Body Fat Gain
Phase 4
Completed
41 enrolled
Brigham and Women's Hospital
National Institute on Aging (NIA) · collab
NaSingle-groupOpen-labelBasic science
Summary
This study aims to investigate the impact of menopause-related sleep fragmentation on metabolic biomarkers of body fat gain. The investigators hypothesize that experimental sleep fragmentation will result in an adverse leptin response as a metabolic biomarker for body fat gain.
Timeline
- Start
- 2017-07-15
- Primary completion
- 2022-08-01
- Completion
- 2022-08-01
Outcome
Mixed primary results
registry analysis (superiority test); Sleep Fragmentation - Active vs Sleep Fragmentation - Control; p = 0.22; Mixed Models Analysis NCT03047330 ↗
registry analysis (superiority test); Estradiol Withdrawal - Active vs Estradiol Withdrawal - Control; p = 0.001; Mixed Models Analysis NCT03047330 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Leuprolide | Other / unclassified | 3.75 mg | — |
Indications
No indication recorded.