Impact of Hot Flashes on Sleep and Mood Disturbance

Study Overview
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Brief Summary
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We plan to enroll premenopausal women in a trial investigating the impact of hot flashes developed in response to an injection of a gonadotropin-releasing hormone agonist (GnRHa), leuprolide (brand name: Lupron), on sleep disruption and mood. This study is designed to mimic the menopause transition. We will collect data on sleep disruption and mood changes to assess their relationship to the development of hot flashes.

Official Title
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Impact of Experimentally Induced Hot Flashes on Sleep and Mood Disturbance

Conditions
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Menopause, Depression, Hot Flashes

Intervention / Treatment
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* Drug: leuprolide


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 or currently breastfeeding Hot flushes Mid-luteal phase progesterone <3ng/mL Clinically significant abnormalities in screening blood tests BMI > 35 kg/m2 Previously diagnosed osteoporosis or osteopenia Clinically significant depressive symptoms Psychiatric illness Sleep apnea or periodic limb movement of sleep (PLMS) Contraindication, hypersensitivity, or previous allergic reaction to GnRH agonists Current or recent use of centrally active medications Current or recent use of systemic hormone medications Night shift workers Current use of over-the-counter (OTC) medications that may affect hot flashes, sleep, or mood Abnormal vaginal bleeding History of any medical diseases that may put subject at risk when treated with study medication.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GnRH Agonist Injection<br>We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants. | Drug: leuprolide<br>* Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).<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 Wake After Sleep Onset (WASO) | Wake after sleep onset (WASO) is calculated by averaging the number of minutes spent awake after initiating sleep each night from the two ambulatory polysomnography studies conducted at baseline and the two ambulatory polysomnography studies conducted four weeks after the GnRHa injection. | baseline and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asperg Depression Rating Scale (MADRS) | The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms. It has a range of 0-60 with higher scores indicating greater symptom burden. Participants were assessed at baseline and four weeks after the GnRHa injection in order to calculate the change in MADRS score. | baseline and 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hot Flashes, Sleep disturbance, Lupron, Menopause