Understanding Experimentally Induced Hot Flushes

Mass General Brigham

Status and phase: Completed; Phase 4

Conditions: Hot Flashes

Treatments: Drug: Leuprolide acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00455689

2005P-001512

Details and patient eligibility

About

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.

Enrollment: 20 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
• 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Developed hot flashes

Experimental group

Description:

Subjects who developed hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Treatment:

Drug: Leuprolide acetate

Did not develop hot flashes

Experimental group

Description:

Subjects who did not develop hot flashes after receiving leuprolide acetate (3.75 mg intramuscular injection)

Treatment:

Drug: Leuprolide acetate