Understanding Experimentally Induced Hot Flushes

Study Overview
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Brief Summary
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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.

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

Conditions
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Hot Flashes

Intervention / Treatment
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* Drug: Leuprolide acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Developed hot flashes<br>Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) | Drug: Leuprolide acetate<br>* 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.<br>* Other names: Lupron;|
| Experimental: Did not develop hot flashes<br>Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection) | Drug: Leuprolide acetate<br>* 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.<br>* Other names: Lupron;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupron, Premenopausal, Hot flashes