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Trial record 64 of 2075 for:    ESTRADIOL

ELITE: Early Versus Late Intervention Trial With Estradiol

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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

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
Enrollment 643
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Postmenopause 17B-estradiol Early Postmenopause Placebo Late Postmenopause 17B-estradiol Late Postmenopause Placebo
Hide Arm/Group Description Early postmenopause, <6 years-since-menopause oral 17B-estradiol 1 mg daily Early postmenopause <6 years-since-menopause Late postmenopause >10 years-since-menopause oral 17B-estradiol 1 mg daily Late postmenopause >10 years-since-menopause
Period Title: Overall Study
Started 137 134 186 186
Completed 125 123 172 176
Not Completed 12 11 14 10
Arm/Group Title Early Postmenopause 17B-estradiol Early Postmenopause Placebo Late Postmenopause 17B-estradiol Late Postmenopause Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 125 123 172 176 596
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 125 participants 123 participants 172 participants 176 participants 596 participants
55.4
(53.2 to 57.9)
55.4
(52.5 to 57.8)
64.3
(60.5 to 68.6)
63.0
(59.9 to 67.0)
60.0
(55.5 to 64.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 123 participants 172 participants 176 participants 596 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 123 participants 172 participants 176 participants 596 participants
White, non-hispanic
88
  70.4%
73
  59.3%
127
  73.8%
127
  72.2%
415
  69.6%
Black, non-hispanic
7
   5.6%
14
  11.4%
17
   9.9%
14
   8.0%
52
   8.7%
Hispanic
16
  12.8%
20
  16.3%
20
  11.6%
23
  13.1%
79
  13.3%
Asian
14
  11.2%
16
  13.0%
8
   4.7%
12
   6.8%
50
   8.4%
1.Primary Outcome
Title Rate of Change of Distal Common Carotid Artery (CCA) Far Wall Intima-media Thickness (IMT)
Hide Description [Not Specified]
Time Frame Twice at baseline and then every 6 months on trial
Hide Outcome Measure Data
Hide Analysis Population Description
Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline.
Arm/Group Title 17B-estradiol Placebo
Hide Arm/Group Description:

Oral 17B-estradiol 1 mg daily

Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily

Matched placebo oral 17B-estradiol daily

Placebo: Matched placebo oral 17B-estradiol

Overall Number of Participants Analyzed 297 299
Mean (95% Confidence Interval)
Unit of Measure: mm per year
Early postmenopause group
0.0044
(0.0026 to 0.0061)
0.0078
(0.0060 to 0.0096)
Late postmenopause group
0.0100
(0.0085 to 0.0115)
0.0088
(0.0073 to 0.0103)
2.Secondary Outcome
Title Change in Neurocognitive Function (Global Cognition)
Hide Description 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.
Time Frame Baseline and at 2.5 years and 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Early postmenopause group (<6 years since menopause) at baseline and late postmenopause group (>10 years since menopause) at baseline. Sample size represents the number of participants with analyzable data collected at baseline, 2.5 years and 5.0 years.
Arm/Group Title 17B-estradiol Placebo
Hide Arm/Group Description:

Oral 17B-estradiol 1 mg daily

Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily

Matched placebo oral 17B-estradiol daily

Placebo: Matched placebo oral 17B-estradiol

Overall Number of Participants Analyzed 284 283
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Early postmenopause group
0.42
(0.11 to 0.73)
0.40
(-0.07 to 0.72)
Late postmenopause group
0.29
(0.14 to 0.44)
0.36
(0.20 to 0.53)
3.Secondary Outcome
Title Number of Participants With Coronary Artery Calcium Measured by Cardiac Computed Tomography
Hide Description measurement of coronary artery calcium at end of study
Time Frame End of randomized treatment
Hide Outcome Measure Data
Hide Analysis Population Description
CAC data was obtained in 380 participants. Participants who were not taking the study agents 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.
Arm/Group Title 17B-estradiol Placebo
Hide Arm/Group Description:

Oral 17B-estradiol 1 mg daily

Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily

Matched placebo oral 17B-estradiol daily

Placebo: Matched placebo oral 17B-estradiol

Overall Number of Participants Analyzed 188 192
Measure Type: Count of Participants
Unit of Measure: Participants
Early postmenopause group
34
  18.1%
24
  12.5%
Late postmenopause gorup
57
  30.3%
65
  33.9%
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events collected per intervention
 
Arm/Group Title 17B-estradiol Placebo
Hide Arm/Group Description

Oral 17B-estradiol 1 mg daily

Oral 17B-estradiol: Oral 17B-estradiol 1 mg daily

Matched placebo oral 17B-estradiol daily

Placebo: Matched placebo oral 17B-estradiol

All-Cause Mortality
17B-estradiol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/323 (0.31%)      1/320 (0.31%)    
Show Serious Adverse Events Hide Serious Adverse Events
17B-estradiol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   43/323 (13.31%)      45/320 (14.06%)    
Blood and lymphatic system disorders     
aplastic anemia   1/323 (0.31%)  1 0/320 (0.00%)  0
Cardiac disorders     
unstable angina   2/323 (0.62%)  2 0/320 (0.00%)  0
atrial fibrillation   1/323 (0.31%)  1 1/320 (0.31%)  1
pleuropericarditis   0/323 (0.00%)  0 1/320 (0.31%)  1
myocardial infarction   1/323 (0.31%)  1 3/320 (0.94%)  3
Ear and labyrinth disorders     
veritgo   1/323 (0.31%)  1 0/320 (0.00%)  0
Gastrointestinal disorders     
ischemic colitis   1/323 (0.31%)  1 0/320 (0.00%)  0
gastroesophageal reflux disease   1/323 (0.31%)  1 0/320 (0.00%)  0
illeitis   1/323 (0.31%)  1 0/320 (0.00%)  0
gastrointestinal hemorrhage   1/323 (0.31%)  1 1/320 (0.31%)  1
pancreatitis   1/323 (0.31%)  1 0/320 (0.00%)  0
ulcerative colitis   0/323 (0.00%)  0 1/320 (0.31%)  1
General disorders     
death   1/323 (0.31%)  1 1/320 (0.31%)  1
non-cardiac chest pain   2/323 (0.62%)  2 1/320 (0.31%)  1
Immune system disorders     
drug hypersensitivity   1/323 (0.31%)  1 0/320 (0.00%)  0
Infections and infestations     
cellulitis   0/323 (0.00%)  0 2/320 (0.63%)  2
lobar pneumonia   0/323 (0.00%)  0 1/320 (0.31%)  1
pelvic abscess   1/323 (0.31%)  1 0/320 (0.00%)  0
pneumonia   1/323 (0.31%)  1 1/320 (0.31%)  1
Injury, poisoning and procedural complications     
cervical vertebral fracture   0/323 (0.00%)  0 1/320 (0.31%)  1
femoral neck fracture   1/323 (0.31%)  1 3/320 (0.94%)  3
foot fracture   0/323 (0.00%)  0 1/320 (0.31%)  1
fracture   0/323 (0.00%)  0 1/320 (0.31%)  1
Musculoskeletal and connective tissue disorders     
systemic lupus erythematosus   1/323 (0.31%)  1 0/320 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma   0/323 (0.00%)  0 1/320 (0.31%)  1
breast cancer   5/323 (1.55%)  5 4/320 (1.25%)  4
breast cancer in situ   5/323 (1.55%)  5 4/320 (1.25%)  4
colon adenoma   0/323 (0.00%)  0 1/320 (0.31%)  1
colorectal cancer   3/323 (0.93%)  3 2/320 (0.63%)  2
gastric cancer   0/323 (0.00%)  0 1/320 (0.31%)  1
glioblastoma   1/323 (0.31%)  1 0/320 (0.00%)  0
malignant peritoneal neoplasm   0/323 (0.00%)  0 1/320 (0.31%)  1
mycosis fungoides   1/323 (0.31%)  1 0/320 (0.00%)  0
ovarian epithelial cancer   0/323 (0.00%)  0 1/320 (0.31%)  1
pancreatic carcinoma   0/323 (0.00%)  0 1/320 (0.31%)  1
polycythemia vera   0/323 (0.00%)  0 1/320 (0.31%)  1
uterine cancer   2/323 (0.62%)  2 1/320 (0.31%)  1
Nervous system disorders     
amnesia   0/323 (0.00%)  0 1/320 (0.31%)  1
dizziness   1/323 (0.31%)  1 0/320 (0.00%)  0
syncope   1/323 (0.31%)  1 1/320 (0.31%)  1
transient ischemic attack   1/323 (0.31%)  1 2/320 (0.63%)  2
Psychiatric disorders     
Suicide ideation   0/323 (0.00%)  0 1/320 (0.31%)  1
psychotic disorder   1/323 (0.31%)  1 0/320 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
pulmonary embolism   2/323 (0.62%)  2 0/320 (0.00%)  0
Surgical and medical procedures     
spinal laminectomy   0/323 (0.00%)  0 1/320 (0.31%)  1
Vascular disorders     
deep vein thrombosis   1/323 (0.31%)  1 2/320 (0.63%)  2
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
17B-estradiol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   216/323 (66.87%)      226/320 (70.63%)    
General disorders     
chest discomfort   23/323 (7.12%)  23 22/320 (6.88%)  22
non-cardiac chest pain   18/323 (5.57%)  18 12/320 (3.75%)  12
Immune system disorders     
drug hypersensitivity   26/323 (8.05%)  26 25/320 (7.81%)  25
Infections and infestations     
bronchitis   19/323 (5.88%)  19 22/320 (6.88%)  22
influenza   44/323 (13.62%)  44 52/320 (16.25%)  52
sinusitis   24/323 (7.43%)  24 24/320 (7.50%)  24
urinary tract infection   63/323 (19.50%)  63 64/320 (20.00%)  64
Injury, poisoning and procedural complications     
contusion   17/323 (5.26%)  17 12/320 (3.75%)  12
fall   37/323 (11.46%)  37 36/320 (11.25%)  36
road traffic accident   19/323 (5.88%)  19 13/320 (4.06%)  13
Musculoskeletal and connective tissue disorders     
arthralgia   47/323 (14.55%)  47 53/320 (16.56%)  53
back pain   35/323 (10.84%)  35 32/320 (10.00%)  32
pain in extremity   10/323 (3.10%)  10 18/320 (5.63%)  18
Psychiatric disorders     
depression   17/323 (5.26%)  17 20/320 (6.25%)  20
Reproductive system and breast disorders     
cervical dysplasia   48/323 (14.86%)  48 42/320 (13.13%)  42
vaginal discharge   17/323 (5.26%)  17 8/320 (2.50%)  8
vulvovaginal pruritis   19/323 (5.88%)  19 11/320 (3.44%)  11
Respiratory, thoracic and mediastinal disorders     
cough   25/323 (7.74%)  25 19/320 (5.94%)  19
Skin and subcutaneous tissue disorders     
rash   16/323 (4.95%)  16 22/320 (6.88%)  22
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Howard N. Hodis, M.D., Director, Atherosclerosis Research Unit
Organization: University of Southern California
Phone: 323 442 1478
EMail: athero@usc.edu
Layout table for additonal information
Responsible Party: Howard Hodis, University of Southern California
ClinicalTrials.gov 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