Understanding Experimentally Induced Hot Flushes

Hot Flashes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455689
• Other study ID #: 2005P-001512
• Status: Completed
• Phase: Phase 4
• Start date: November 28, 2005
• Est. completion date: September 2, 2007

Study information

• Verified date: August 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2, 2007
• Est. primary completion date: July 24, 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Hot Flashes

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Endocrine Research Society

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline (before receiving intervention) and 4 weeks after receiving intervention
Secondary	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.	baseline (before receiving intervention) and 4 weeks after receiving intervention