Understanding Experimentally Induced Hot Flushes
|ClinicalTrials.gov Identifier: NCT00455689|
Recruitment Status : Unknown
Verified April 2012 by Hadine Joffe, MD, Massachusetts General Hospital.
Recruitment status was: Active, not recruiting
First Posted : April 4, 2007
Last Update Posted : April 26, 2012
The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. Hot flushes (or "hot flashes") are a feeling of being overheated, and often are followed by heavy sweating, skin becoming red and hot, and discomfort. Sometimes hot flushes are followed by chills. Some women experience a rapid heart rate. Hot flushes that happen at night are called night sweats, and they may interfere with sleep.
The investigators will cause hot flushes by giving study participants a hormone medication called leuprolide (Lupron). Hormones are chemicals that are naturally produced in the body. Leuprolide is a manufactured (artificial) hormone that will make the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide.
The investigators will also evaluate changes in sleep, mood, and feelings of well-being over the course of the study. The investigators will use questionnaires to measure these changes.
|Condition or disease||Intervention/treatment||Phase|
|Hot Flashes||Drug: Leuprolide acetate (Lupron)||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Understanding Experimentally Induced Hot Flushes|
|Study Start Date :||November 2005|
|Primary Completion Date :||September 2007|
|Estimated Study Completion Date :||October 2012|
|Experimental: Leuprolide Depot (GnRH agonist)||
Drug: Leuprolide acetate (Lupron)
Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection
Leuprolide is a widely used GnRH agonist that is manufactured by TAP Pharmaceutical Products. Leuprolide 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.
- To examine the impact of hot flushes on sleep, mood, and well-being. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ]Experimentally induced hot flushes will correlate with impairment of sleep and mood.
- To describe the hormonal dynamics after administration of a gonadotropin-releasing hormone agonist that are associated with the development of hot flushes. [ Time Frame: Baseline and post-treatment (4 weeks after GnRH agonist) ]Changes in reproductive hormones after administration of a gonadotropin-releasing hormone will differ between those who do and do not develop hot flushes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455689
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hadine Joffe, M.D., M.Sc.||Massachusetts General Hospital|