Understanding Experimentally Induced Hot Flushes

Massachusetts General Hospital20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Hot Flashes

Interventions

Leuprolide acetateDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Massachusetts General Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention

Secondary Outcomes

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.

Time frame: baseline (before receiving intervention) and 4 weeks after receiving intervention

Data from ClinicalTrials.gov

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