Understanding Experimentally Induced Hot Flushes

Completed · Phase 4

Conditions studied: Hot Flashes

In brief

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.

Key facts

Study ID

NCT00455689

Run by

Massachusetts General Hospital

People needed

20

Starts

2005-11-28

Expected to finish

2007-09-02

Last updated by the study team

2018-09-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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