Impact of Hot Flashes on Sleep and Mood Disturbance
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01116401|
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : December 26, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menopause Depression Hot Flashes||Drug: leuprolide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance|
|Actual Study Start Date :||November 3, 2009|
|Actual Primary Completion Date :||December 29, 2011|
|Actual Study Completion Date :||January 4, 2012|
Experimental: GnRH Agonist Injection
We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
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).
Other Name: Lupron
- Percent Change in Wake After Sleep Onset (WASO) [ Time Frame: baseline and 4 weeks ]Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection.
- Change in Montgomery-Asperg Depression Rating Scale (MADRS) [ Time Frame: baseline and 4 weeks ]The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score.
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): NCT01116401
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Hadine Joffe, MD||Brigham and Women's Hospital|