Study Evaluating Changes In Mammographic Breast Density

CompletedOBSERVATIONAL
Enrollment

507

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Osteoporosis
Interventions
DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (26)

14642

Pfizer Investigational Site, Rochester

15090

Pfizer Investigational Site, Wexford

22908

Pfizer Investigational Site, Charlottesville

23507

Pfizer Investigational Site, Norfolk

27609

Pfizer Investigational Site, Raleigh

29605

Pfizer Investigational Site, Greenville

30033

Pfizer Investigational Site, Decatur

32606

Pfizer Investigational Site, Gainesville

33409

Pfizer Investigational Site, West Palm Beach

33916

Pfizer Investigational Site, Fort Myers

34652

Pfizer Investigational Site, New Port Richey

40291

Pfizer Investigational Site, Lousiville

45267

Pfizer Investigational Site, Cincinnati

48034

Pfizer Investigational Site, Southfield

55318

Pfizer Investigational Site, Chaska

59102

Pfizer Investigational Site, Billings

60610

Pfizer Investigational Site, Chicago

75390

Pfizer Investigational Site, Dallas

78229

Pfizer Investigational Site, San Antonio

89146

Pfizer Investigational Site, Las Vegas

40536-0293

Pfizer Investigational Site, Lexington

08901

Pfizer Investigational Site, New Brunswick

01308-050

Pfizer Investigational Site, São Paulo

1782 GZ

Pfizer Investigational Site, Nijmegen

NO-5094

Pfizer Investigational Site, Bergen

NO-2317

Pfizer Investigational Site, Hamar

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY