search
Back to results

Understanding Experimentally Induced Hot Flushes

Primary Purpose

Hot Flashes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Leuprolide acetate
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hot Flashes focused on measuring Lupron, Premenopausal, Hot flashes

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
  • 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

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Developed hot flashes

Did not develop hot flashes

Arm Description

Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Outcomes

Primary Outcome Measures

Percent Change in Objective Sleep Efficiency
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

Change in Subjective Sleep Quality
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.

Full Information

First Posted
April 2, 2007
Last Updated
August 20, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Endocrine Research Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00455689
Brief Title
Understanding Experimentally Induced Hot Flushes
Official Title
Understanding Experimentally Induced Hot Flushes and Their Impact on Sleep and Mood
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 28, 2005 (Actual)
Primary Completion Date
July 24, 2007 (Actual)
Study Completion Date
September 2, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Endocrine Research Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes
Keywords
Lupron, Premenopausal, Hot flashes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Developed hot flashes
Arm Type
Experimental
Arm Description
Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Arm Title
Did not develop hot flashes
Arm Type
Experimental
Arm Description
Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Other Intervention Name(s)
Lupron
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in Objective Sleep Efficiency
Description
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.
Time Frame
baseline (before receiving intervention) and 4 weeks after receiving intervention
Secondary Outcome Measure Information:
Title
Change in Subjective Sleep Quality
Description
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.
Time Frame
baseline (before receiving intervention) and 4 weeks after receiving intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hadine Joffe, M.D., M.Sc.
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
22723326
Citation
Joffe H, Deckersbach T, Lin NU, Makris N, Skaar TC, Rauch SL, Dougherty DD, Hall JE. Metabolic activity in the insular cortex and hypothalamus predicts hot flashes: an FDG-PET study. J Clin Endocrinol Metab. 2012 Sep;97(9):3207-15. doi: 10.1210/jc.2012-1413. Epub 2012 Jun 20.
Results Reference
derived

Learn more about this trial

Understanding Experimentally Induced Hot Flushes

We'll reach out to this number within 24 hrs