RNA Expression Analysis Of Endometrial Biopsies Comparing Placebo, Bazedoxifene/ Conjugated Estrogens And Raloxifene
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
研究概览
简要总结
This study is an observational study analyzing the biopsy samples collected from subjects that participated in Study 3115A1-303 (NCT00675688). These endometrial biopsy samples will be de-identified at an anatomical laboratory and then sent to a molecular biology lab where an RNA extraction and analysis will be performed. The purpose of this study is to compare specific endometrial gene regulation at the level of mRNA expression in samples from placebo, bazedoxifene/conjugated estrogens, and raloxifene treated groups with a known set of genes that have been previously identified to be associated with estrogenization, endometrial hyperplasia, and endometrial cancer.
详细描述
The termination date was June 23, 2010. The study was terminated because the endometrial biopsy blocks from the 3115A1-303 study that were to be used for this study need to be retained and accessible in case of a regulatory inspection of the 303 protocol. Additionally, the Brazilian sites were not likely not to receive national IRB (CONEP) approval, and enrollment could not be met without the inclusion of these subjects. The study was not terminated due to safety concerns.
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
- •Each subject must have participated in study 3115A1-303 and must have satisfied all of the following criteria:
- •Has completed 24 months of treatment.
- •Was at least 80% compliant with study drug administration.
排除标准
- •Endometrial biopsy at baseline, month 6 or month 24 that were technically unacceptable
- •Did not have an endometrial biopsy at all of the required timepoints (baseline, month 6, month 24)
研究组 & 干预措施
Bazedoxifene 10 mg/CE 0.625 mg
干预措施: Bazedoxifene 10 mg/CE 0.625 mg (Drug)
Bazedoxifene 20 mg/CE 0.625 mg
干预措施: Bazedoxifene 20 mg/CE 0.625 mg (Drug)
Bazedoxifene 40 mg/CE 0.625 mg
干预措施: Bazedoxifene 40 mg/CE 0.625 mg (Drug)
Bazedoxifene 10 mg/CE 0.45 mg
干预措施: Bazedoxifene 10 mg/CE 0.45 mg (Drug)
Bazedoxifene 20 mg/CE 0.45 mg
干预措施: Bazedoxifene 20 mg/CE 0.45 mg (Drug)
Bazedoxifene 40 mg/CE 0.45 mg
干预措施: Bazedoxifene 40 mg/CE 0.45 mg (Drug)
Raloxifene 60 mg
干预措施: Raloxifene 60 mg (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Endometrial gene regulation at the level of mRNA expression in placebo, Bazedoxifene/CE, and raloxifene treated groups
时间窗: Baseline, 6 months and 24 months
次要结局
未报告次要终点