Status:
COMPLETED
EPAT: Estrogen in the Prevention of Atherosclerosis Trial
Lead Sponsor:
National Institute on Aging (NIA)
Collaborating Sponsors:
Mead Johnson Nutrition
Conditions:
Atherosclerosis
Postmenopause
Eligibility:
FEMALE
46-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine the effects of estrogen replacement therapy (ERT) on the progression of early atherosclerosis in healthy postmenopausal women without preexisting cardiovascul...
Detailed Description
The primary goal of this randomized, controlled trial is to determine if ERT stabilizes, retards, and/or reverses the progression of atherosclerosis in postmenopausal women. We will further evaluate t...
Eligibility Criteria
Inclusion
- Postmenopausal female (serum estradiol less than 20 pg/ml)
- 46 to 80 years old
- Fasting LDL-C levels 130 to 210 mg/dL
- Triglyceride levels less than 400 mg/dL
- Current non-smoker
Exclusion
- Clinical evidence of cardiovascular disease
- HDL-C level less than 30 mg/dL
- Fasting blood glucose greater than 200 mg/dL
- Previous hormonal replacement therapy (non-contraceptive) over 10 years duration and/or current use within 1 month
- Uncontrolled hypertension
- Untreated thyroid disease
- Renal insufficiency
- Clinical evidence of congestive heart failure
- Life threatening disease with prognosis less than 5 years
- Alcohol intake greater than 5 drinks per day (1 drink = 1 1/2 oz distilled spirits, 4 oz wine, or 12 oz beer) or substance abuse (intravenous drug abuse, cocaine use)
- History of estrogen dependent cancer or detected at screening or any other disorder precluding use of ERT
- Hot flashes greater than 5 per day which interfere with daily activity and preclude randomization to placebo.
Key Trial Info
Start Date :
April 1 1994
Trial Type :
INTERVENTIONAL
End Date :
November 1 1998
Estimated Enrollment :
222 Patients enrolled
Trial Details
Trial ID
NCT00115024
Start Date
April 1 1994
End Date
November 1 1998
Last Update
December 11 2009
Active Locations (1)
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1
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033