NCT00470561已完成不适用
The Effect of Aspirin on Mammogram Density (TEAM)
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
研究概览
简要总结
RATIONALE: Aspirin may be effective in reducing breast density in healthy postmenopausal women with a moderate or high level of breast density.
PURPOSE: This randomized clinical trial is studying the effect of aspirin on mammogram density compared with a placebo in healthy postmenopausal women with a moderate or high level of breast density.
详细描述
OBJECTIVES:
Primary
- Compare the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density in healthy postmenopausal women with a moderate or high level of breast density.
Secondary
- Determine whether there is a differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms.
- Determine the effect of aspirin therapy on potential adverse events, including gastrointestinal symptoms and signs, bleeding events, blood pressure, and other major comorbidities and hospitalizations, as well as generalized symptoms, in these participants.
- Determine the effects of aspirin therapy on putative biomarkers of breast and ovarian cancer that are currently being validated as part of ongoing Fred Hutchinson Cancer Research Center Ovarian SPORE activities.
- Determine the effects of aspirin therapy on levels of serum estradiol, estrone and sex hormone binding globulin (SHBG) as measured by radioimmunoassay at baseline and 6 month timepoints
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Aspirin
Active Comparator
干预措施: Aspirin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of the effect of acetylsalicylic acid (aspirin) vs placebo on mammographic density
时间窗: Baseline and end-of-study (6 month timepoint)
次要结局
- Differential response in mammogram density to aspirin treatments in individual homozygous wild-type, heterozygous, and homozygous variant for several UGT gene polymorphisms(Baseline and end-of-study (6 month timepoint))
- Adverse events(Collected over the course of tehestudy)
- Putative biomarkers of breast and ovarian cancer(Baseline and end-of-study (6 month timepoint))
- Comparison of the effect of aspiring vs placebo on serum levels of estradiol, estrone and sex hormone binding globulin(Baseline and 6 month timepoints)
研究者
研究点 (1)
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