ELITE: Early Versus Late Intervention Trial With Estradiol - Tabular View

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ELITE: Early Versus Late Intervention Trial With Estradiol

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

ELITE: Early Versus Late Intervention Trial With Estradiol

Official Title ^†

Biologic Response of Menopausal Women to 17B-Estradiol

Brief Summary

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

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.

Study Phase

Phase II, Phase III

Study Type ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

neurocognitive function

Condition ^†

Atherosclerosis

Intervention ^†

Drug: 17B-estradiol

MEDLINE PMIDs

Links

USC Atherosclerosis Research Unit ELITE Trial This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

504

Start Date ^†

July 2004

Completion Date

June 2009

Eligibility 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)

Gender

Female

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00114517

Organization ID

AG0025

Secondary IDs ^††

R01AG024154

Study Sponsor ^†

National Institute on Aging (NIA)

Collaborators ^††

Investigators ^†

Principal Investigator:

Howard N. Hodis, MD

University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine

Information Provided By

National Institute on Aging (NIA)

Verification Date

December 2007

First Received Date ^†

June 15, 2005

Last Updated Date

December 17, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.