Status:
COMPLETED
Midlife Cholesterol Study
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
University of Washington
Conditions:
Menopause
Postmenopause
Eligibility:
FEMALE
47-55 years
Phase:
PHASE4
Brief 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 o...
Detailed Description
Women with the Metabolic Syndrome (central obesity, insulin resistance, and dyslipidemia) are at especially high risk for coronary heart disease (CHD). The prevalence of the Metabolic Syndrome increas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 1998
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00361075
Start Date
July 1 1998
End Date
May 1 2005
Last Update
November 5 2014
Active Locations (2)
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1
Northwestern University
Chicago, Illinois, United States, 60611
2
University of Washington
Seattle, Washington, United States, 98195