Impact of Hot Flashes on Sleep and Mood Disturbance

• Status: Completed
• Trial end date: 2012-01-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hadine Joffe, MD; Massachusetts General Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Deslorelin; Leuprolide

Criteria

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.