Overview

This trial is active, not recruiting.

Condition atherosclerosis
Treatments oral 17b-estradiol, placebo
Phase phase 2/phase 3
Sponsor University of Southern California
Collaborator National Institute on Aging (NIA)
Start date July 2004
End date December 2012
Trial size 643 participants
Trial identifier NCT00114517, AG0025, R01AG024154

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Oral 17B-estradiol 1 mg daily
oral 17b-estradiol Estrace
Oral 17B-estradiol 1 mg daily
(Placebo Comparator)
Matched placebo oral 17B-estradiol daily
placebo
Matched placebo oral 17B-estradiol

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
neurocognitive function
time frame: Baseline and at 3 years and end of randomized treatment
cardiac computed tomography
time frame: End of randomized treatment

Eligibility Criteria

Female participants of any age.

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)

Additional Information

Official title Biologic Response of Menopausal Women to 17B-Estradiol
Principal investigator Howard N. Hodis, MD
Description The primary hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of early atherosclerosis if initiated soon after menopause when the vascular endothelium (lining of blood vessels) is relatively healthy versus later when the endothelium has lost its responsiveness to estrogen. Ultrasonography will be used to measure the rate of change in the thickness of the carotid artery and cardiac computed tomography (CT) will be used to measure coronary artery calcium and coronary artery lesions. The second hypothesis to be tested is that 17B-estradiol (estrogen) will reduce the progression of cognitive decline if initiated soon after menopause when healthy brain tissue remains responsive to estrogen versus later when brain tissue has lost its responsiveness to estrogen. A total of 643 (actual)(504, initially proposed) postmenopausal women were randomized according to their number of years since menopause, less than 6 years or 10 years or more, to receive either oral 17B-estradiol 1 mg daily or a placebo. Women with a uterus will also use vaginal progesterone gel 4% (or a placebo gel) the last ten days of each month. The vaginal progesterone will be distributed in a double-blind fashion along with the randomized treatment so that only women exposed to active treatment will receive active progesterone. As initially proposed, participants will undergo ultrasonography at baseline and every 6 months throughout the 2 to 5 years (average 3 years) of randomized treatment. Participants will also undergo cognitive testing at baseline and after 3 years of randomized treatment. The trial has been extended for an additional 2 to 2.5 years of randomized treatment (overall average randomized treatment of 5 years and range of 2 to 8.5 years). Ultrasonography will continue to be collected every 6 months and upon completion of randomized treatment, participants will undergo cardiac CT for coronary artery calcium and coronary artery lesion measurements. Participants will also undergo a third cognitive testing at the completion of randomized treatment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by University of Southern California.