Status:
COMPLETED
ELITE: Early Versus Late Intervention Trial With Estradiol
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Atherosclerosis
Eligibility:
FEMALE
Phase:
PHASE2
Brief Summary
The purpose of this study is to examine the effects of oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy postmenopausal women.
Detailed Description
The primary hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of early atherosclerosis if initiated soon after menopause when the vascular endothelium (lining of blo...
Eligibility Criteria
Inclusion
- Women with a serum estradiol level 25 pg/ml or less
- No period for 6 months or more
- Postmenopausal less than 6 years, OR 10 years or longer
Exclusion
- Clinical signs, symptoms, or personal history of cardiovascular disease
- Women who have had a hysterectomy only and no oophorectomy (since time from menopause cannot be determined)
- Diabetes mellitus or fasting serum glucose 140 mg/dL or greater
- Uncontrolled hypertension (diastolic blood pressure 110 mmHg or greater)
- Thyroid disease (untreated)
- Serum creatinine greater than 2.0 mg/dL
- Plasma triglyceride levels greater than 500 mg/dL
- Life threatening disease with prognosis less than 5 years
- Cirrhosis or liver disease
- History of deep vein thrombosis or pulmonary embolism
- History of breast cancer
- Current hormone replacement therapy (HRT)
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2013
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00114517
Start Date
July 1 2004
End Date
March 5 2013
Last Update
January 18 2023
Active Locations (1)
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1
Atherosclerosis Research Unit, University of Southern California
Los Angeles, California, United States, 90033