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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 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 517 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02524561
The ClinicalTrials.gov registry entry for NCT02524561 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 517 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Estradiol patch is the first listed.
NCT02524561 reports 0 study locations.
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.
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