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

June 15, 2005
June 17, 2010
July 2004
December 2012   (final data collection date for primary outcome measure)
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 ]
rate of change of distal common carotid artery (CCA) far wall intima-media thickness (IMT)
Complete list of historical versions of study NCT00114517 on ClinicalTrials.gov Archive Site
  • 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
neurocognitive function
Not Provided
Not Provided
 
ELITE: Early Versus Late Intervention Trial With Estradiol
Biologic Response of Menopausal Women to 17B-Estradiol

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Atherosclerosis
  • Drug: Oral 17B-estradiol
    Oral 17B-estradiol 1 mg daily
    Other Names:
    • Estrace
    • Estrogen replacement therapy
    • Estrogen
  • Drug: Placebo
    Matched placebo oral 17B-estradiol
  • Active Comparator: 17B-estradiol
    Oral 17B-estradiol 1 mg daily
    Intervention: Drug: Oral 17B-estradiol
  • Placebo Comparator: Placebo
    Matched placebo oral 17B-estradiol daily
    Intervention: Drug: Placebo
Henderson VW. Aging, estrogens, and episodic memory in women. Cogn Behav Neurol. 2009 Dec;22(4):205-14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
643
July 2013
December 2012   (final data collection date for primary outcome measure)

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)
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00114517
AG0025, R01AG024154
Yes
Howard N. Hodis, MD, USC
University of Southern California
National Institute on Aging (NIA)
Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
University of Southern California
June 2010

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