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. Identifier: NCT00114517
Recruitment Status : Completed
First Posted : June 16, 2005
Results First Posted : June 8, 2017
Last Update Posted : June 8, 2017
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Howard Hodis, University of Southern California

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Atherosclerosis
Interventions: Drug: Oral 17B-estradiol
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Early Postmenopause 17B-estradiol Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily
Early Postmenopause Placebo Early postmenopause <6 years-since-menopause
Late Postmenopause 17B-estradiol Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily
Late Postmenopause Placebo Late postmenopause >10 years-since-menopause

Participant Flow:   Overall Study
    Early Postmenopause 17B-estradiol   Early Postmenopause Placebo   Late Postmenopause 17B-estradiol   Late Postmenopause Placebo
STARTED   137   134   186   186 
COMPLETED   125   123   172   176 
NOT COMPLETED   12   11   14   10 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Early Postmenopause 17B-estradiol No text entered.
Early Postmenopause Placebo No text entered.
Late Postmenopause 17B-estradiol No text entered.
Late Postmenopause Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
   Early Postmenopause 17B-estradiol   Early Postmenopause Placebo   Late Postmenopause 17B-estradiol   Late Postmenopause Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 125   123   172   176   596 
[Units: Years]
Median (Inter-Quartile Range)
 (53.2 to 57.9) 
 (52.5 to 57.8) 
 (60.5 to 68.6) 
 (59.9 to 67.0) 
 (55.5 to 64.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      125 100.0%      123 100.0%      172 100.0%      176 100.0%      596 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
White, non-hispanic   88   73   127   127   415 
Black, non-hispanic   7   14   17   14   52 
Hispanic   16   20   20   23   79 
Asian   14   16   8   12   50 

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Change in Neurocognitive Function (Global Cognition)   [ Time Frame: Baseline and at 2.5 years and 5 years ]

3.  Secondary:   Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography   [ Time Frame: End of randomized treatment ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Howard N. Hodis, M.D., Director, Atherosclerosis Research Unit
Organization: University of Southern California
phone: 323 442 1478

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Howard Hodis, University of Southern California Identifier: NCT00114517     History of Changes
Other Study ID Numbers: AG0025
R01AG024154 ( U.S. NIH Grant/Contract )
First Submitted: June 15, 2005
First Posted: June 16, 2005
Results First Submitted: April 17, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017