Understanding Experimentally Induced Hot Flushes
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|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|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|