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Impact of Hot Flashes on Sleep and Mood Disturbance

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ClinicalTrials.gov Identifier: NCT01116401
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : December 26, 2017
Last Update Posted : January 23, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Brief 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.

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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: GnRH Agonist Injection
We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.
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).
Other Name: Lupron



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women 18-45 years old
  • Premenopausal
  • Willingness to use barrier methods of contraception during study and after completion of study until menses resume
  • Good general health

Exclusion Criteria:

  • Pregnancy or currently breastfeeding
  • Hot flushes
  • Mid-luteal phase progesterone <3ng/mL
  • Clinically significant abnormalities in screening blood tests
  • BMI > 35 kg/m2
  • Previously diagnosed osteoporosis or osteopenia
  • Clinically significant depressive symptoms
  • Psychiatric illness
  • Sleep apnea or periodic limb movement of sleep (PLMS)
  • Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
  • Current or recent use of centrally active medications
  • Current or recent use of systemic hormone medications
  • Night shift workers
  • Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood
  • Abnormal vaginal bleeding
  • History of any medical diseases that may put subject at risk when treated with study medication.

Information from the National Library of Medicine

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


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Hadine Joffe, MD Brigham and Women's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hadine Joffe, MD, Vice Chair for Psychiatry Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01116401     History of Changes
Other Study ID Numbers: 2009-P-001557
5R01MH082922 ( U.S. NIH Grant/Contract )
First Posted: May 5, 2010    Key Record Dates
Results First Posted: December 26, 2017
Last Update Posted: January 23, 2018
Last Verified: December 2017

Keywords provided by Hadine Joffe, MD, Brigham and Women's Hospital:
Hot Flashes
Sleep disturbance
Lupron
Menopause

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms
Leuprolide
Deslorelin
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action