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Understanding Experimentally Induced Hot Flushes

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ClinicalTrials.gov Identifier: NCT00455689
Recruitment Status : Completed
First Posted : April 4, 2007
Results First Posted : August 21, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Endocrine Research Society
Information provided by (Responsible Party):
Hadine Joffe, MD, Brigham and Women's Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hot Flashes Drug: Leuprolide acetate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
Actual Study Start Date : November 28, 2005
Actual Primary Completion Date : July 24, 2007
Actual Study Completion Date : September 2, 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Lupron


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
  • 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
Contacts and Locations
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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): NCT00455689


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Endocrine Research Society
Investigators
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Principal Investigator: Hadine Joffe, M.D., M.Sc. Brigham and Women's Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hadine Joffe, MD, Vice Chair for Psychiatry Research, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00455689    
Other Study ID Numbers: 2005P-001512
First Posted: April 4, 2007    Key Record Dates
Results First Posted: August 21, 2018
Last Update Posted: September 18, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hadine Joffe, MD, Brigham and Women's Hospital:
Lupron
Premenopausal
Hot flashes
Additional relevant MeSH terms:
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Hot Flashes
Leuprolide
Fertility Agents, Female
Fertility Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents