CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 643 enrolled
Drug / intervention
17B-estradiol +1 moredrug
Likely dose
17β-estradiol 1 mg orally dailyAI-extracted
Key inclusion· 3
  • ✓Serum estradiol level 25 pg/mL or less
  • ✓No menstrual period for 6 months or more
  • ✓Postmenopausal less than 6 years OR 10 years or longer (gap of 6-10 years excluded)
Key exclusion· 11
  • ✕Clinical signs, symptoms, or personal history of cardiovascular disease
  • ✕Diabetes mellitus or fasting serum glucose ≥140 mg/dL
  • ✕Uncontrolled hypertension (diastolic ≥110 mmHg)
  • ✕Untreated thyroid disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00114517
NCT00114517Phase 2Completed
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Biologic Response of Menopausal Women to 17B-Estradiol

University of Southern California·interventional·Posted Jun 16, 2005·Updated Jan 18, 2023

In Brief

A Phase 2 clinical trial evaluating 17B-estradiol and Placebo for Atherosclerosis. Completed, enrolled 643 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtherosclerosis
CountriesUnited States
CollaboratorsNational Institute on Aging (NIA)

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 16, 2005
Enrollment StartJul 1, 2004
Primary CompletionFeb 12, 2013
Study CompletionMar 5, 2013
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 21.0 years ago

Interventions

17B-estradioldrug

Oral 17B-estradiol 1 mg daily

Placeboother

Matching oral 17B-estradiol placebo daily