Study Evaluating Changes In Mammographic Breast Density
NCT ID: NCT00774267
Last Updated: 2014-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
507 participants
OBSERVATIONAL
2009-01-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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1
BZA 20 mg/CE 0.45 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
2
BZA 20 mg/CE 0.625 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
3
Raloxifene 60 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
4
Placebo
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Interventions
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BZA 20 mg/CE 0.45 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
BZA 20 mg/CE 0.625 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Raloxifene 60 mg
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Placebo
There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Eligibility Criteria
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Inclusion Criteria
* Completed 24 months of treatment in protocol 3115A1-303.
* Had a mammogram at the baseline visit and at the month 24 visit in protocol 3115A1-303, and both are original films that are technically acceptable for reading.
* Was at least 80% compliant with test article administration during protocol 3115A1-303.
Exclusion Criteria
* One or both mammograms were digitized when they were obtained during the 3115A1-303 study.
* Had more than one mammogram at either the baseline or month 24 visit of study 3115A1-303.
40 Years
75 Years
FEMALE
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Gainesville, Florida, United States
Pfizer Investigational Site
New Port Richey, Florida, United States
Pfizer Investigational Site
West Palm Beach, Florida, United States
Pfizer Investigational Site
Decatur, Georgia, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Lexington, Kentucky, United States
Pfizer Investigational Site
Lousiville, Kentucky, United States
Pfizer Investigational Site
Southfield, Michigan, United States
Pfizer Investigational Site
Chaska, Minnesota, United States
Pfizer Investigational Site
Billings, Montana, United States
Pfizer Investigational Site
Las Vegas, Nevada, United States
Pfizer Investigational Site
New Brunswick, New Jersey, United States
Pfizer Investigational Site
Rochester, New York, United States
Pfizer Investigational Site
Raleigh, North Carolina, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Pfizer Investigational Site
Wexford, Pennsylvania, United States
Pfizer Investigational Site
Greenville, South Carolina, United States
Pfizer Investigational Site
Dallas, Texas, United States
Pfizer Investigational Site
San Antonio, Texas, United States
Pfizer Investigational Site
Charlottesville, Virginia, United States
Pfizer Investigational Site
Norfolk, Virginia, United States
Pfizer Investigational Site
São Paulo, RS/Brazil, Brazil
Pfizer Investigational Site
Nijmegen, , Netherlands
Pfizer Investigational Site
Bergen, , Norway
Pfizer Investigational Site
Hamar, , Norway
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B2311010
Identifier Type: -
Identifier Source: secondary_id
3115A1-4000
Identifier Type: -
Identifier Source: org_study_id
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