Official Title: “Biologic Response of Menopausal Women to 17B-Estradiol”

The purpose of this study is to examine the effects of 17B-estradiol (estrogen) on the progression of early atherosclerosis in postmenopausal women.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study

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 blood vessels) is relatively healthy versus later when the endothelium has lost its responsiveness to estrogen. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery.

A total of 504 postmenopausal women will be randomized according to their number of years since menopause, less than 6 years or 10 years or more, to receive either oral 17B-estradiol 1 mg daily or a placebo. Women with a uterus will also use vaginal progesterone gel 4% (or a placebo gel) the last ten days of each month. The vaginal progesterone will be distributed in a double-blind fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone. Participants will receive ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment.

Intervention(s) in this Clinical Trial

• Drug: 17B-estradiol

Primary Measures

• rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)

Secondary Measures

• neurocognitive function

Inclusion Criteria:

• 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 Criteria:

• 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)

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: National Institute on Aging (NIA)

Overall Clinical Trial Officials and Contacts

Howard N. Hodis, MD Principal Investigator University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00114517

Study ID Number: AG0025

ClinicalTrials.gov Identifier: NCT00114517

Health Authority: United States: Federal Government

USC Atherosclerosis Research Unit ELITE Trial