EPAT: Estrogen in the Prevention of Atherosclerosis Trial

Completed · Phase 2/Phase 3

Conditions studied: Atherosclerosis, Postmenopause

In brief

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).

Key facts

Study ID

NCT00115024

Run by

National Institute on Aging (NIA)

People needed

222

Starts

1994-04-01

Expected to finish

1998-11-01

Last updated by the study team

2009-12-11

Who can join

Age: 46 and older, up to 80. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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