Understanding Experimentally Induced Hot Flushes

Phase 4

Completed

• Conditions: Hot Flashes
• Interventions: Drug: Leuprolide acetate

• Registration Number: NCT00455689
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11-28
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-04
• Primary Completion: 2007-07-24
• Study Completion: 2007-09-02
• Results First Submitted: 2017-12-01
• Results First Submitted QC: 2017-12-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-20
• Results First Posted: 2018-08-21
• Last Update Posted: 2018-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Developed hot flashes	Leuprolide acetate	Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)
Did not develop hot flashes	Leuprolide acetate	Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Primary Outcome Measures

Name	Time	Method
Percent Change in Objective Sleep Efficiency	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

Name	Time	Method
Change in Subjective Sleep Quality	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States