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NCT03047330 · ClinicalTrials.gov registry record · Phase 4
Menopausal Sleep Fragmentation and Body Fat Gain
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 41
- Enrollment target
NCT03047330: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT03047330 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 41 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03047330, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 41 participants
- Enrollment target
Study 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.
Primary Outcome
12-hr overnight fasted AM (morning) blood samples were assayed for leptin levels on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 samples\]. For each individual, leptin values were normalized relative to the mean baseline leptin value. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Interventions
- DRUG Estradiol withdrawal
- OTHER Fragmented sleep
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2017-07-15 |
| Est. Completion | 2022-08-01 |
| Phase | Phase 4 |
What the finished NCT03047330 record still lists
NCT03047330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Estradiol withdrawal is the first listed.
NCT03047330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03047330 about?
NCT03047330 is a clinical study titled "Menopausal Sleep Fragmentation and Body Fat Gain". 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.
What is the current status of trial NCT03047330?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 41 participants. The study started on 2017-07-15. Estimated completion is 2022-08-01.
What interventions are being tested in trial NCT03047330?
The interventions under investigation include: Estradiol withdrawal (DRUG), Fragmented sleep (OTHER).
Who is sponsoring clinical trial NCT03047330?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03047330's enrollment target sits among peer trials
41 1390th of 2000 higher than 604 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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