Midlife Cholesterol Study

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The postmenopausal state is associated with an increase risk for heart disease. Much of this increase in risk may be due to the loss of estrogen (the main female hormone) and the effect of this loss on lipids (blood fats). This loss of estrogen is often treated by estrogen replacement therapy. Estrogen replacement therapy seems to have a beneficial effect on lipid levels. The purpose of this research study is to understand 1) how menopause affects lipids and 2) how hormone replacement therapy effects the lipid metabolism of postmenopausal women.

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

Details

• Lead Sponsor: Northwestern University
• Collaborator: University of Washington
• Treatments: Estradiol; Estrogens; Progesterone

Criteria

Inclusion Criteria:

• Have demonstrated an interest to participate in the ERT trial

• Be premenopausal (have menstrual period in previous three months) prior to start of observational arm

• Prior to start of interventional arm (ERT), the women must be postmenopausal (have not had a menstrual cycle in the past twelve months and FSH >30)

• Be between the ages of 47 and 55

• Not be taking any form of estrogen replacement

• Have an intact uterus and at least one ovary and normal screening mammogram in the 12 months prior to starting ERT

Exclusion Criteria:

• Body mass index (kg/m2) greater than 40 kg/m2

• History of diabetes mellitus or fasting >110 mg/dl at screening

• Abnormal fasting LDL or triglyceride

• Use of lipid lowering medications, beta-blockers, birth control pills

• Active liver disease (recent history of active hepatitis, jaundice, scleral icterus, and/or elevated liver function tests

• History of breast, endometrial or ovarian cancer

• History of thrombotic disorder (past history of pulmonary embolus or deep venous thrombosis) or known history of CAD