CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 517 enrolled
Drug / intervention
CEE pill +5 moredrug
Likely dose
CEE pill 0.45 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02524561
NCT02524561N/ACompleted

KEEPS Mammographic Density And Breast Health Ancillary Study

Brigham and Women's Hospital·interventional·Posted Aug 17, 2015·Updated Mar 8, 2017

In Brief

A clinical study evaluating CEE pill, Estradiol patch, and 4 other interventions for Mammographic Density and Abnormal Mammogram. Completed, enrolled 517 participants across 1 site.

Detailed Summary

Combined estrogen and progestin therapy has been shown to increase mammographic density and incidence of breast cancer in randomized trials. The investigators propose to examine the effects of now commonly used low-dose combined hormone therapy (HT) regimens on breast density, rates of abnormal mammogram, and circulating estrogens in the ongoing, already-funded Kronos Early Estrogen Prevention Study (KEEPS). KEEPS is a randomized clinical trial with a primary goal of examining the effects of low-dose transdermal versus oral estrogen combined with cyclic micronized progesterone on progression of subclinical atherosclerosis in recently menopausal women. Prior studies of low-dose HT have been of short duration and small size. By determining the effects of low-dose hormone therapy on the breast, the proposed ancillary study will add important information about the estimated balance of risks and benefits associated with low-dose HT and will help guide future research trials.

Study Details

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2015
Enrollment StartSep 1, 2005
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 10.9 years ago

Interventions

CEE pilldrug

Conjugated equine estrogens 0.45 mg/day

Estradiol patchdrug

Climara 50 mcg/day

Active Progesteronedrug

Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime

Placebo tabletother

Placebo tablet

Placebo patchother

placebo patch

Placebo progesteroneother

placebo progesterone