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Study Evaluating Changes In Mammographic Breast Density

NCT00774267 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 507

Last updated 2014-04-08

Study results available
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Summary

The objective of the study is to evaluate quantitative changes in mammographic breast density from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this study is the change in mammographic breast density between baseline and month 24 for each group.

Conditions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States
  • Brazil
  • Netherlands
  • Norway

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00774267 on ClinicalTrials.gov