Understanding Experimentally Induced Hot Flushes

• Status: Completed
• Trial end date: 2007-09-02
• Target enrollment: 0
• Participant gender: Female

Summary

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.

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

Details

• Lead Sponsor: Hadine Joffe, MD; Massachusetts General Hospital
• Collaborator: Endocrine Research Society
• Treatments: 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

• 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