Study Evaluating Changes In Mammographic Breast Density

Evaluation Of Changes In Mammographic Breast Density Associated With Bazedoxifene Acetate/Conjugated Estrogens, Raloxifene And Placebo In Postmenopausal Women: An Ancillary Study Of Protocol 3115A1-303-WW

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.

Inclusion Criteria:

• Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.
• 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:

• Had a mammogram at either baseline or month 24 during the 3115A1-303 study that was technically unsatisfactory.
• 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.