Impact of Hot Flashes on Sleep and Mood Disturbance

Mass General Brigham

Status and phase

Completed

Phase 4

Conditions

Menopause

Hot Flashes

Depression

Treatments

Drug: leuprolide

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01116401

5R01MH082922 (U.S. NIH Grant/Contract)

2009-P-001557

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.