What this trial studies
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.
Conditions in scope
- Menopause
Interventions
- Estradiol withdrawal (Drug) — one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
- Fragmented sleep (Other) — Fragmented sleep will be experimentally induced.
Who can join
Women only · Ages 18 Years to 45 Years · Accepts healthy volunteers.
Inclusion criteria
- Healthy premenopausal women 18-45 years old
- Regular sleep schedule
- Limited alcohol and caffeine intake
- Regular monthly menstrual cycles
- No lifetime history of hot flashes
- Willingness to use approved methods of contraception during study
- Not obese
- Good general health
Exclusion criteria
- Contraindication, hypersensitivity or previous adverse reaction to gonadotropin releasing hormone agonists
- Pregnancy
- Breastfeeding
- Tobacco use
- Contraindicated systemic hormone medications or centrally active medications
- Shift workers or recent/expected time zone travel
- Obstructive sleep apnea
- Insomnia symptoms
Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.
Where it’s happening
| City | State / Region | Facility | Site status |
|---|---|---|---|
| Boston | Massachusetts | Brigham & Women's Hospital | Unknown |
Status & timeline
- Overall status: Completed
- Study type: Interventional
- Phase: PHASE4
- Start date: 2017-07-15
- Primary completion: 2022-08-01
- Last update posted: 2024-10-08
- First posted: 2017-02-08
Sponsor & contact
Lead sponsor: Brigham and Women's Hospital (Other)
Collaborators: National Institute on Aging (NIA)
For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.
Outcome measures
Primary outcomes
- Normalized Serum Leptin Levels (pre/post sleep fragmentation (3 days); pre/post estradiol withdrawal (~5 weeks))
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).
Related ClearedRx care
If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.
Important. Information from ClinicalTrials.gov as of May 8, 2026. Trial details (status, sites, contacts, eligibility, outcomes) change frequently — always check the official record at https://clinicaltrials.gov/study/NCT03047330 before contacting a site.
ClearedRx is not affiliated with this trial or its sponsor. We index public-domain ClinicalTrials.gov records to help patients find evidence-based context for menopause care decisions. ClearedRx itself is a telehealth menopause/HRT brand — we do not enroll patients in trials.