Phase 2
Completed N=643
ELITE: Early Versus Late Intervention Trial With Estradiol
Source: ClinicalTrials.gov NCT00114517 ↗Enrolled (actual)
643
Serious AEs
13.7%
Results posted
Jun 2017
Primary outcomePrimary: Progression of Subclinical Atherosclerosis — 0.0044; 0.0078; 0.0100; 0.0088 mm per year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression of Subclinical Atherosclerosis |
0.0044; 0.0078; 0.0100; 0.0088 | — |
| SECONDARY Change in Neurocognitive Function (Global Cognition) |
0.42; 0.40; 0.29; 0.36 | — |
| SECONDARY Coronary Artery Calcium |
34; 24; 57; 65 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00114517). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.