NCT01116401

Impact of Hot Flashes on Sleep and Mood Disturbance

Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Menopause
• Depression
• Hot Flashes

Interventions

Type	Name	Description
DRUG	leuprolide	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).

Timeline

• Start date: 2009-11-03
• Primary completion: 2011-12-29
• Completion: 2012-01-04
• First posted: 2010-05-05
• Last updated: 2018-01-23
• Results posted: 2017-12-26

Locations

1 site across 1 country: United States