EPAT: Estrogen in the Prevention of Atherosclerosis Trial

• Status: Completed
• Trial end date: 1998-11-01
• Target enrollment: 0
• Participant gender: Female

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 cardiovascular disease (CVD).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute on Aging (NIA)
• Collaborator: Mead Johnson Nutrition
• Treatments: Estradiol; Estrogens

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.