NCT00455689

Understanding Experimentally Induced Hot Flushes

Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hot Flashes

Interventions

Type	Name	Description
DRUG	Leuprolide acetate	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.

Timeline

• Start date: 2005-11-28
• Primary completion: 2007-07-24
• Completion: 2007-09-02
• First posted: 2007-04-04
• Last updated: 2018-09-18
• Results posted: 2018-08-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study