At a glance
ClinicalIndex Comparison Record- ✓Healthy premenopausal women aged 18–45 years
- ✓Regular monthly menstrual cycles
- ✓No lifetime history of hot flashes
- ✓Not obese with good general health
- ✕Contraindication, hypersensitivity, or previous adverse reaction to GnRH agonists
- ✕Pregnancy or breastfeeding
- ✕Tobacco use
- ✕Contraindicated systemic hormone medications or centrally active medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Menopausal Sleep Fragmentation: Impact on Body Fat Gain Biomarkers in Women
In Brief
A Phase 4 clinical trial evaluating Estradiol withdrawal and Fragmented sleep for Menopause. Completed, enrolled 41 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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 will be experimentally induced.