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NCT02694809 · ClinicalTrials.gov registry record · Phase 2

The PROMISE Study: Duavee in Women With DCIS

A Phase 2 study, sponsored by Northwestern University.

Completed
Registry status
Phase 2
Development phase
142
Enrollment target

NCT02694809 is a Phase 2 study that has completed, run by Northwestern University. The registered enrollment target is 142 participants.

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The verdict

NCT02694809, a Phase 2 study, has completed, sponsored by Northwestern University.

COMPLETED
Registry status
Phase 2
Development phase
142 participants
Enrollment target

Study Summary

The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopausal women to treat certain symptoms of menopause such as hot flashes. Since it is not approved in women with DCIS, its use in this study is experimental. This study will also look at whether taking the study drug causes any significant or undesirable side effects in women with DCIS. The researchers hope that this study will help them determine if taking the study drug is safe in women taking DCIS and if it can possibly reduce the risk of developing breast cancer in women with DCIS.

Interventions

  • OTHER Placebo
  • OTHER Laboratory Biomarker Analysis
  • PROCEDURE Quality-of-Life Assessment
  • OTHER Pharmacological Study
  • DRUG Conjugated Estrogens/Bazedoxifene

Trial Details

FieldValue
Enrollment Target 142 participants
Start Date 2017-01
Est. Completion 2024-06-19
Phase Phase 2

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT02694809

The ClinicalTrials.gov registry entry for NCT02694809 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT02694809 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02694809 about?

NCT02694809 is a clinical study titled "The PROMISE Study: Duavee in Women With DCIS". The main purpose of this study is to determine if taking the study drug, conjugated estrogens/bazedoxifene (Duavee®) causes any changes in the proliferation markers within the breast tissue of the study subjects. The study drug is approved by the US Food and Drug Administration in healthy postmenopa...

What is the current status of trial NCT02694809?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2017-01. Estimated completion is 2024-06-19.

What interventions are being tested in trial NCT02694809?

The interventions under investigation include: Placebo (OTHER), Laboratory Biomarker Analysis (OTHER), Quality-of-Life Assessment (PROCEDURE), Pharmacological Study (OTHER), Conjugated Estrogens/Bazedoxifene (DRUG).

Who is sponsoring clinical trial NCT02694809?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.