Impact of Hot Flashes on Sleep and Mood Disturbance

Phase 4

Completed

Brief Summary: 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.

Recruitment & 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 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.

Arm && Interventions

Group	Intervention	Description
GnRH Agonist Injection	leuprolide	We will be administering an injection of leuprolide acetate (a GnRH agonist) to all participants.

Primary Outcome Measures

Name	Time	Method
Percent Change in Wake After Sleep Onset (WASO)	baseline and 4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in Montgomery-Asperg Depression Rating Scale (MADRS)	baseline and 4 weeks	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.