ELITE: Early Versus Late Intervention Trial With Estradiol

• Status: Completed
• Trial end date: 2013-03-05
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Southern California
• Collaborator: National Institute on Aging (NIA)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Estrogens; Polyestradiol phosphate

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)