ELITE: Early Versus Late Intervention Trial With Estradiol
Information source: National Institute on Aging (NIA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atherosclerosis
Intervention: 17B-estradiol (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: National Institute on Aging (NIA) Official(s) and/or principal investigator(s):
Howard N. Hodis, MD, Principal Investigator, Affiliation: University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Summary
The purpose of this study is to examine the effects of 17B-estradiol (estrogen) on the
progression of early atherosclerosis in postmenopausal women.
Clinical Details
Official title: Biologic Response of Menopausal Women to 17B-Estradiol
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Efficacy Study
Primary outcome: rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Secondary outcome: neurocognitive function
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 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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
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)
Locations and Contacts
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine, Los Angeles, California 90033, United States; Recruiting
Howard N. Hodis, MD, Phone: 866-240-1489, Email: aru@usc.edu
Additional Information
USC Atherosclerosis Research Unit ELITE Trial
Starting date: July 2004
Ending date: June 2009
Last updated: August 21, 2008
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