ELITE: Early Versus Late Intervention Trial With Estradiol

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Southern California.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00114517
First received: June 15, 2005
Last updated: June 17, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Atherosclerosis
Drug: Oral 17B-estradiol
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Biologic Response of Menopausal Women to 17B-Estradiol

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT) [ Time Frame: Twice at baseline and then every 6 months on trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • neurocognitive function [ Time Frame: Baseline and at 3 years and end of randomized treatment ] [ Designated as safety issue: No ]
  • cardiac computed tomography [ Time Frame: End of randomized treatment ] [ Designated as safety issue: No ]
    measurement of coronary artery calcium and coronary artery lesions


Enrollment: 643
Study Start Date: July 2004
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 17B-estradiol
Oral 17B-estradiol 1 mg daily
Drug: Oral 17B-estradiol
Oral 17B-estradiol 1 mg daily
Other Names:
  • Estrace
  • Estrogen replacement therapy
  • Estrogen
Placebo Comparator: Placebo
Matched placebo oral 17B-estradiol daily
Drug: Placebo
Matched placebo oral 17B-estradiol

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 and cardiac computed tomography (CT) will be used to measure coronary artery calcium and coronary artery lesions. The second hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of cognitive decline if initiated soon after menopause when healthy brain tissue remains responsive to estrogen versus later when brain tissue has lost its responsiveness to estrogen.

A total of 643 (actual)(504, initially proposed) postmenopausal women were 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. As initially proposed, participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment. Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment. The trial has been extended for an additional 2 to 2.5 years of randomized treatment (overall average randomized treatment of 5 years and range of 2 to 8.5 years). Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment, participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements. Participants will also undergo a third cognitive testing at the completion of randomized treatment.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00114517

Locations
United States, California
Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
  More Information

Additional Information:
No publications provided by University of Southern California

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Howard N. Hodis, MD, USC
ClinicalTrials.gov Identifier: NCT00114517     History of Changes
Other Study ID Numbers: AG0025, R01AG024154
Study First Received: June 15, 2005
Last Updated: June 17, 2010
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
estrogen
estrogen therapy
hormone therapy
atherosclerosis
CAD
cardiac computed tomography
cardiovascular disease
carotid artery intima-media thickness
cognitive function
computed tomography
coronary artery calcium
coronary artery disease
coronary artery lesions
CVD
postmenopausal
subclinical vascular disease
timing hypothesis
ultrasonography

Additional relevant MeSH terms:
Estrogens
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Estradiol
Polyestradiol phosphate
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 19, 2014