Pilot Study of Bazedoxifene Plus Conjugated Estrogen on Imaging and Blood Biomarkers
NCT04821375 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2025-10-29
Summary
Pilot study to test feasibility of 6 months of bazedoxifene (BZA) plus conjugated estrogens (CE) to modulate breast MRI parameters.
Conditions
- Increased Risk for Development of Breast Cancer
Interventions
- DRUG
-
bazedoxifene plus conjugated estrogens
6 months of bazedoxifene (20 mg) and conjugated estrogens (0.45 mg) taken together daily.
Sponsors & Collaborators
-
Carol Fabian, MD
lead OTHER
Principal Investigators
-
Carol J Fabian, MD · University of Kansas Medical Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Max Age
- 65 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-02
- Primary Completion
- 2024-05-20
- Completion
- 2024-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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