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Gonadotropin-releasing hormone (GnRH) agonist

Fragmented sleep for Menopause

Phase 4
Waitlist Available
Led By Hadine Joffe, MD MSc
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-hour overnight fasted morning sample
Awards & highlights

Study Summary

This trial will study how menopause-related sleep disruption affects a woman's metabolism, specifically how it causes weight gain.

Eligible Conditions
  • Menopause

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-hour overnight fasted morning sample
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-hour overnight fasted morning sample for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Leptin
Secondary outcome measures
Satiety

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Sleep fragmentation - activeExperimental Treatment1 Intervention
Participants after 3 nights of experimentally-fragmented sleep
Group II: Estradiol withdrawal - activeExperimental Treatment1 Intervention
Participants after experimentally-induced hypo-estradiol
Group III: Sleep fragmentation - controlActive Control1 Intervention
Participants after 2 nights of unfragmented sleep
Group IV: Estradiol withdrawal - controlActive Control1 Intervention
Participants during high-estradiol phase of menstrual cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Estradiol withdrawal
2017
Completed Phase 4
~130

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,760 Total Patients Enrolled
16 Trials studying Menopause
3,088 Patients Enrolled for Menopause
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,825 Total Patients Enrolled
8 Trials studying Menopause
122,701 Patients Enrolled for Menopause
Hadine Joffe, MD MScPrincipal Investigator - Brigham and Women's Hospital
Brigham & Women's Faulkner Hospital, Brigham & Women's Hospital
Joan And Stanford I. Weill Medical College Of Cornell Uni (Medical School)
Mass Gen Hospital (Residency)
4 Previous Clinical Trials
174 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Menopausal Sleep Fragmentation and Body Fat Gain
Hadine Joffe, MD MSc 2017. "Menopausal Sleep Fragmentation and Body Fat Gain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03047330.
~16 spots leftby Apr 2025
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