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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 507
- 试验地点
- 1
- 主要终点
- Percent Change From Baseline in Mammographic Breast Density at Month 24
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who have completed all scheduled evaluations in protocol 3115A1-303-WW.
- •Completed 24 months of treatment in protocol 3115A1-
- •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.
排除标准
- •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.
研究组 & 干预措施
1
干预措施: BZA 20 mg/CE 0.45 mg (Drug)
2
干预措施: BZA 20 mg/CE 0.625 mg (Drug)
3
干预措施: Raloxifene 60 mg (Drug)
4
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Mammographic Breast Density at Month 24
时间窗: primary study baseline, Month 24
The digitized mammogram pairs were analyzed by a single trained radiologist who determined the density of the breast using software. The only left craniocaudal view was used for assessing breast density.
次要结局
未报告次要终点