Understanding Experimentally Induced Hot Flushes

August 20, 2018 updated by: Hadine Joffe, MD, Massachusetts General Hospital

Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood

The purpose of the study is to examine the impact of hot flushes on sleep, mood, and well-being. The investigators will cause hot flushes by giving study participants the hormone medication, leuprolide (Lupron), which is a manufactured (artificial) hormone that makes the body think that it has reached menopause temporarily. Most women begin to have hot flushes within 4 weeks after taking leuprolide and resume menses 3 months later. The investigators will administer questionnaires to evaluate changes in sleep and mood over the course of the study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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
  • Breastfeeding
  • Hot flushes
  • Hemoglobin at the screening visit less than 10 gm/dL
  • Abnormal liver function tests
  • Abnormal renal function tests
  • BMI > 35 kg/m2
  • Previously diagnosed osteoporosis or osteopenia
  • Psychiatric disorder involving mood, anxiety, psychotic disorder, current anorexia nervosa, or current alcohol or substance-use disorder
  • Previous severe depression
  • Evidence of suicidal or homicidal ideation
  • Sleep apnea, narcolepsy, or other diagnosed sleep disorder
  • Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists
  • Regular use of centrally active medications
  • Use of hormonal medications for at least 2 months
  • Use of ketoconazole, clomiphene citrate, or anabolic/androgenic steroids in the preceding 3 months
  • Renal insufficiency
  • Abnormal vaginal bleeding
  • History of thrombo-embolism or cardiovascular disease
  • History of congestive heart failure or other conditions requiring sodium restriction
  • History of spinal cord compression
  • Metastatic vertebral lesions
  • Memory disorders
  • Urinary tract obstruction
  • History of liver, kidney, pulmonary, or metabolic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Developed hot flashes
Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Drug: Leuprolide acetate

Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection

Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that 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.

Other Names:
  • Lupron
Experimental: Did not develop hot flashes
Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Drug: Leuprolide acetate

Leuprolide acetate (Lupron Depot®) 3.75-mg intramuscular injection

Leuprolide is a widely used gonadotropin-releasing hormone agonist (GnRHa) that 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.

Other Names:
  • Lupron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Objective Sleep Efficiency
Time Frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Objective sleep efficiency was measured using actigraphy. Sleep efficiency (percent of time spent asleep between bedtime and wake time) was calculated and averaged over 2 consecutive nights both before and 4 weeks after receiving the intervention.
baseline (before receiving intervention) and 4 weeks after receiving intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Subjective Sleep Quality
Time Frame: baseline (before receiving intervention) and 4 weeks after receiving intervention
Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI; range 0-21, higher score indicates poorer quality sleep), which was administered both before and four weeks after receiving the intervention.
baseline (before receiving intervention) and 4 weeks after receiving intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Endocrine Research Society

Investigators

  • Principal Investigator: Hadine Joffe, M.D., M.Sc., Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2005

Primary Completion (Actual)

July 24, 2007

Study Completion (Actual)

September 2, 2007

Study Registration Dates

First Submitted

April 2, 2007

First Submitted That Met QC Criteria

April 2, 2007

First Posted (Estimate)

April 4, 2007

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005P-001512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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