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NCT02524561 · ClinicalTrials.gov registry record · NA
KEEPS Mammographic Density And Breast Health Ancillary Study
A NA study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 517
- Enrollment target
NCT02524561: Completed NA study, sponsored by Brigham and Women's Hospital.
NCT02524561 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 517 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02524561, a NA study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 517 participants
- Enrollment target
Study 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.
Primary Outcome
Breast density prior to randomization. Frequency of the BIRADS category according to randomization status. BIRADS is a 1-4 category of breast density as assessed by a radiologist. 1= most fatty and least dense, while 4=most dense.
Interventions
- DRUG Estradiol patch
- OTHER Placebo tablet
- OTHER Placebo patch
- DRUG CEE pill
- DRUG Active Progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 517 participants |
| Start Date | 2005-09 |
| Est. Completion | 2013-12 |
| Phase | NA |
What the finished NCT02524561 record still lists
NCT02524561 is an interventional study that assigns participants to a tested intervention. The registered 517 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 5 interventions - of which Estradiol patch is the first listed.
NCT02524561 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02524561 about?
NCT02524561 is a clinical study titled "KEEPS Mammographic Density And Breast Health Ancillary Study". 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 mamm...
What is the current status of trial NCT02524561?
This trial is currently completed. It is a NA study. The enrollment target is 517 participants. The study started on 2005-09. Estimated completion is 2013-12.
What interventions are being tested in trial NCT02524561?
The interventions under investigation include: Estradiol patch (DRUG), Placebo tablet (OTHER), Placebo patch (OTHER), CEE pill (DRUG), Active Progesterone (DRUG).
Who is sponsoring clinical trial NCT02524561?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02524561's enrollment target sits among peer trials
517 191st of 2000 higher than 1,810 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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