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Impact of Hot Flashes on Sleep and Mood Disturbance

Primary Purpose

Menopause, Depression, Hot Flashes

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

leuprolide

About this trial

This is an interventional basic science trial for Menopause focused on measuring Hot Flashes, Sleep disturbance, Lupron, Menopause

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GnRH Agonist Injection

Arm Description

We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.

Outcomes

Primary Outcome Measures

Percent Change in Wake After Sleep Onset (WASO)

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

Change in Montgomery-Asperg Depression Rating Scale (MADRS)

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.

Full Information

NCT ID

NCT01116401

First Posted

May 3, 2010

Last Updated

December 26, 2017

Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT01116401

Brief Title

Impact of Hot Flashes on Sleep and Mood Disturbance

Official Title

Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

November 3, 2009 (Actual)

Primary Completion Date

December 29, 2011 (Actual)

Study Completion Date

January 4, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopause, Depression, Hot Flashes

Keywords

Hot Flashes, Sleep disturbance, Lupron, Menopause

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GnRH Agonist Injection

Arm Type

Experimental

Arm Description

We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.

Intervention Type

Drug

Intervention Name(s)

leuprolide

Other Intervention Name(s)

Lupron

Intervention Description

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).

Primary Outcome Measure Information:

Title

Percent Change in Wake After Sleep Onset (WASO)

Description

Time Frame

baseline and 4 weeks

Secondary Outcome Measure Information:

Title

Change in Montgomery-Asperg Depression Rating Scale (MADRS)

Description

Time Frame

baseline and 4 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hadine Joffe, MD

Organizational Affiliation

Brigham and Women's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

27680875

Citation

Joffe H, Crawford SL, Freeman MP, White DP, Bianchi MT, Kim S, Economou N, Camuso J, Hall JE, Cohen LS. Independent Contributions of Nocturnal Hot Flashes and Sleep Disturbance to Depression in Estrogen-Deprived Women. J Clin Endocrinol Metab. 2016 Oct;101(10):3847-3855. doi: 10.1210/jc.2016-2348. Epub 2016 Sep 28.

Results Reference

derived

PubMed Identifier

26951410

Citation

Bianchi MT, Kim S, Galvan T, White DP, Joffe H. Nocturnal Hot Flashes: Relationship to Objective Awakenings and Sleep Stage Transitions. J Clin Sleep Med. 2016 Jul 15;12(7):1003-9. doi: 10.5664/jcsm.5936. Erratum In: J Clin Sleep Med. 2016 Oct 15;12(10):1431.

Results Reference

derived

PubMed Identifier

24293774

Citation

Joffe H, Crawford S, Economou N, Kim S, Regan S, Hall JE, White D. A gonadotropin-releasing hormone agonist model demonstrates that nocturnal hot flashes interrupt objective sleep. Sleep. 2013 Dec 1;36(12):1977-85. doi: 10.5665/sleep.3244.

Results Reference

derived

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Impact of Hot Flashes on Sleep and Mood Disturbance

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