Completed
PHASE4
INTERVENTIONAL
NCT01116401
Impact of Hot Flashes on Sleep and Mood Disturbance
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.
Interventions
Name:
leuprolide
Type:
DRUG
Description:
Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).
Primary Outcomes
Measure:
Percent Change in Wake After Sleep Onset (WASO)
TimeFrame:
baseline and 4 weeks
Description:
Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.
Trial Information
NCT ID
NCT01116401
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Massachusetts General Hospital
Last Updated
December 15, 2025