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).
12-hr overnight fasted AM satiety scores were collected on study days 2-6 under both estrogenized and estradiol-withdrawal conditions \[total: 10 scores\]. For each individual, satiety scores were normalized relative to the mean baseline satiety score. Baseline was defined as the unfragmented estrogenized condition (avg. of study days 2-3 in the estrogenized condition).
Group
Value
95% CI
Sleep Fragmentation - Active
99.2
± 11.9
Sleep Fragmentation - Control
113.1
± 11.0
Estradiol Withdrawal - Active
102.6
± 15.6
Estradiol Withdrawal - Control
109.3
± 7.8
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07472881 — Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women
· NA
· recruiting
NCT07135232 — The Effects of Resistance Training and a Plant-Based Supplement on Perimenopausal Symptoms and Muscle Health.
· NA
· recruiting
NCT06975111 — Focusing on the Menopausal Transition to Improve Mid-Life Women's Health
· Phase 2, PHASE3
· recruiting
NCT07393672 — Effects of Hemp-Derived Cannabinoids on Menopause Symptoms
· Phase 2
· recruiting
NCT07412093 — The Effect of Progressive Relaxation Exercises and Planned Education on Menopausal Symptoms, Perceived Stress, and Anxie
· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
Last refreshed: 8 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03047330.