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

Tracking Information

First Received Date ^ICMJE

June 15, 2005

Last Updated Date

August 21, 2008

Start Date ^ICMJE

July 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00114517 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

neurocognitive function

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

ELITE: Early Versus Late Intervention Trial With Estradiol

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Atherosclerosis

Intervention ^ICMJE

Drug: 17B-estradiol

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

504

Completion Date

June 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00114517

Responsible Party

Howard N. Hodis, MD, USC

Study ID Numbers ^ICMJE

AG0025, R01AG024154

Study Sponsor ^ICMJE

National Institute on Aging (NIA)

Collaborators ^ICMJE

Investigators ^ICMJE

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

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP