At a glance
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Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
In Brief
A Phase 4 clinical trial evaluating Leuprolide acetate for Hot Flashes. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.