Understanding Experimentally Induced Hot Flushes - DSIP Clinical Trial

Brief Summary

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.

Interventions

Name: Leuprolide acetate

Type: DRUG

Description: Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that is indicated for treatment of endometriosis, uterine fibroids, precocious puberty, and prostate cancer, and is used off-label for in-vitro fertilization and premenstrual syndrome. In this protocol, leuprolide will be administered once during the mid-luteal phase of the menstrual cycle at a dose routinely used for treatment of endometriosis and uterine fibroids in women.

Primary Outcomes

Measure: Percent Change in Objective Sleep Efficiency

TimeFrame: baseline (before receiving intervention) and 4 weeks after receiving intervention

Description: Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.

Trial Information

NCT ID

NCT00455689

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Massachusetts General Hospital

Last Updated

December 15, 2025