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ELITE: Early Versus Late Intervention Trial With Estradiol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00114517
Recruitment Status : Completed
First Posted : June 16, 2005
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Howard Hodis, University of Southern California

Tracking Information
First Submitted Date  ICMJE June 15, 2005
First Posted Date  ICMJE June 16, 2005
Results First Submitted Date  ICMJE April 17, 2017
Results First Posted Date  ICMJE June 8, 2017
Last Update Posted Date June 8, 2017
Study Start Date  ICMJE July 2004
Actual Primary Completion Date February 12, 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Rate of Change of Distal Common Carotid Artery (CCA) Far Wall Intima-media Thickness (IMT)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2017)
  • Change in Neurocognitive Function (Global Cognition) [ Time Frame: Baseline and at 2.5 years and 5 years ]
    All neuropsychological test scores at baseline and follow-up assessments were standardized ([raw score - mean score]/standard deviation) using the baseline means and standard deviations from the entire ELITE sample. Each of three cognitive composite scores was calculated at baseline and follow-up assessments as the weighted average of the individual donor standardized test scores, weighted by the inverse correlation among tests.The change from baseline (endpoint minus baseline cognitive outcome) was computed for each of the cognitive scores (verbal memory, global cognition, and executive functions). Since the outcome is not a single test but a weighted average of multiple tests, the range is not standard and not reported. Higher scores mean better outcomes.
  • Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography [ Time Frame: End of randomized treatment ]
    measurement of coronary artery calcium at end of study
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
neurocognitive function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 oral 17B-estradiol (estrogen) on the progression of early (subclinical) atherosclerosis and cognitive decline in healthy 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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atherosclerosis
Intervention  ICMJE
  • Drug: Oral 17B-estradiol
    Oral 17B-estradiol 1 mg daily
    Other Names:
    • Estrace
    • Estrogen replacement therapy
    • Estrogen
  • Drug: Placebo
    Matched placebo oral 17B-estradiol
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2009)
643
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
504
Actual Study Completion Date  ICMJE March 5, 2013
Actual Primary Completion Date February 12, 2013   (Final data collection date for primary outcome measure)
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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00114517
Other Study ID Numbers  ICMJE AG0025
R01AG024154 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard Hodis, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Howard N. Hodis, MD University of Southern California, Atherosclerosis Research Unit, Division of Cardiovascular Medicine, Department of Medicine
PRS Account University of Southern California
Verification Date June 2017

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