Trial · NCT00114517

ELITE: Early Versus Late Intervention Trial With Estradiol

NCT00114517, Phase 2, Completed, University of Southern California; results first posted 2017-06-08

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ELITE: Early Versus Late Intervention Trial With Estradiol. Trials, record NCT00114517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00114517

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ELITE: Early Versus Late Intervention Trial With Estradiol
NCT number: NCT00114517
Status: Completed
Phases: Phase 2
Enrollment: 643 participants, actual
Lead sponsor: University of Southern California
Conditions: Atherosclerosis
Interventions: 17B-estradiol, Placebo
First posted: 2005-06-16
Last updated: 2023-01-18
Results first posted: 2017-06-08

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression of Subclinical Atherosclerosis	Baseline x 2 and then every 6 months up to 6.7 years	Rate of change in distal common carotid artery (CCA) far wall intima-media thickness (mm per year) in computer image processed B-mode ultrasonograms that were obtained at two baseline examinations (averaged to obtain the baseline CIMT value) and every 6 months during trial follow-up.
Secondary	Change in Neurocognitive Function (Global Cognition)	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.
Secondary	Coronary Artery Calcium	End of randomized treatment, up to 6.7 years	Number of participants with coronary artery calcium measured by cardiac computed tomography

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression of Subclinical Atherosclerosis	Baseline x 2 and then every 6 months up to 6.7 years	Early postmenopause group (\<6 years-since-menopause) at baseline and late postmenopause group (\>10 years-since-menopause) at baseline.	mm per year	MEAN
SECONDARY	Change in Neurocognitive Function (Global Cognition)	Baseline and at 2.5 years and 5 years	Sample size represents the number of participants with analyzable data collected at baseline, 2.5 years, and 5.0 years. Early postmenopause group (\<6 years-since-menopause) at baseline and late postmenopause group (\>10 years-since-menopause) at baseline.	units on a scale	MEAN
SECONDARY	Coronary Artery Calcium	End of randomized treatment, up to 6.7 years	CAC data was obtained in 380 participants. Participants who were not taking the study products at the last follow-up visit, who had adherence to the study regimen that was lower than 80%, or who had a CAC scan more than 6 months after the final study visit were not included in the analysis. Early postmenopause group (\<6 years-since-menopause) at baseline and late postmenopause group (\>10 years-since-menopause) at baseline.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression of Subclinical Atherosclerosis	17B-estradiol	Early postmenopause group	0.0044	95% Confidence Interval 0.0026 to 0.0061	mm per year
Progression of Subclinical Atherosclerosis	Placebo	Early postmenopause group	0.0078	95% Confidence Interval 0.0060 to 0.0096	mm per year
Progression of Subclinical Atherosclerosis	17B-estradiol	Late postmenopause group	0.0100	95% Confidence Interval 0.0085 to 0.0115	mm per year
Progression of Subclinical Atherosclerosis	Placebo	Late postmenopause group	0.0088	95% Confidence Interval 0.0073 to 0.0103	mm per year
Change in Neurocognitive Function (Global Cognition)	17B-estradiol	Early postmenopause group	0.42	95% Confidence Interval 0.11 to 0.73	units on a scale
Change in Neurocognitive Function (Global Cognition)	Placebo	Early postmenopause group	0.40	95% Confidence Interval -0.07 to 0.72	units on a scale
Change in Neurocognitive Function (Global Cognition)	17B-estradiol	Late postmenopause group	0.29	95% Confidence Interval 0.14 to 0.44	units on a scale
Change in Neurocognitive Function (Global Cognition)	Placebo	Late postmenopause group	0.36	95% Confidence Interval 0.20 to 0.53	units on a scale
Coronary Artery Calcium	17B-estradiol	Early postmenopause group	34		Participants
Coronary Artery Calcium	Placebo	Early postmenopause group	24		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Early Postmenopause 17B-estradiol	137
Overall Study	STARTED	Early Postmenopause Placebo	134
Overall Study	STARTED	Late Postmenopause 17B-estradiol	186
Overall Study	STARTED	Late Postmenopause Placebo	186
Overall Study	COMPLETED	Early Postmenopause 17B-estradiol	125
Overall Study	COMPLETED	Early Postmenopause Placebo	123
Overall Study	COMPLETED	Late Postmenopause 17B-estradiol	172
Overall Study	COMPLETED	Late Postmenopause Placebo	176
Overall Study	NOT COMPLETED	Early Postmenopause 17B-estradiol	12
Overall Study	NOT COMPLETED	Early Postmenopause Placebo	11

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events130

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	chest discomfort	General disorders	17B-estradiol	23	323	23
other	chest discomfort	General disorders	Placebo	22	320	22
other	non-cardiac chest pain	General disorders	17B-estradiol	18	323	18
other	non-cardiac chest pain	General disorders	Placebo	12	320	12
other	drug hypersensitivity	Immune system disorders	17B-estradiol	26	323	26
other	drug hypersensitivity	Immune system disorders	Placebo	25	320	25
other	bronchitis	Infections and infestations	17B-estradiol	19	323	19
other	bronchitis	Infections and infestations	Placebo	22	320	22
other	influenza	Infections and infestations	17B-estradiol	44	323	44
other	influenza	Infections and infestations	Placebo	52	320	52

1 to 10 of 130Source ClinicalTrials.gov

See all 130 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	17B-estradiol	1	323
Total, all-cause mortality	Placebo	1	320
Total, other adverse events	17B-estradiol	216	323
Total, other adverse events	Placebo	226	320
Total, serious adverse events	17B-estradiol	43	323
Total, serious adverse events	Placebo	45	320

Source ClinicalTrials.gov

Papers11

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19996872	DERIVED	PubMed
25380275	BACKGROUND	PubMed
25405497	DERIVED	PubMed
27028912	RESULT	PubMed
27421538	RESULT	PubMed
30272234	DERIVED	PubMed
31362877	DERIVED	PubMed
32925623	DERIVED	PubMed
34736575	DERIVED	PubMed
35526057	DERIVED	PubMed

1 to 10 of 11

See all 11 papers

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AG024154	Biologic Response of Menopausal Women to 17B-Estradiol	HODIS, HOWARD NEIL	UNIVERSITY OF SOUTHERN CALIFORNIA	NATIONAL INSTITUTE ON AGING	2004 to 2012

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
17B-estradiol vs Placebo: deaths from any cause	Trial comparisons
17B-estradiol vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00114517

GET https://conductscience.org/api/trials/v1/NCT00114517/events?page=2

API reference For AI assistants