NCT00084344已完成不适用
A Prospective, Randomized, Placebo-Controlled Trial of the Effects of 4-Hydroxytamoxifen Gel on Breast Density, Salivary Sex Steroids, and Quality of Life in Premenopausal Women
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 试验地点
- 2
研究概览
简要总结
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. 4-hydroxytamoxifen gel (a substance made when tamoxifen breaks down in the body) may be effective in reducing breast density by reducing estrogen levels with fewer side effects than tamoxifen. This may improve quality of life and the ability to detect breast cancer with screening mammography.
PURPOSE: Randomized screening study to determine the effect of 4-hydroxytamoxifen gel on breast density, salivary sex steroids (hormones), and quality of life in premenopausal women.
详细描述
OBJECTIVES:
Primary
- Determine the effect of 4-hydroxytamoxifen gel on breast density, as measured by digital mammography, in premenopausal women.
- Determine the effect of this gel on breast density in these participants, as defined by the BIRADS lexicon.
Secondary
- Determine the effect of this gel on salivary sex steroid levels in these participants.
- Determine the effect of this gel on quality of life of these participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Screening
- 盲法
- Double
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •DISEASE CHARACTERISTICS:
- •Premenopausal as determined by a menstrual history of no change in menstrual pattern within the past 6 months
- •Undergoing mammography at least annually
- •No prior breast cancer
- •No clinical breast abnormalities suspicious for cancer
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status
- •See Disease Characteristics
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Not pregnant or nursing
- •Fertile patients must use effective barrier contraception
- •No medical or psychiatric disorder that would preclude giving informed consent
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •More than 3 months since prior oral contraceptives or other estrogen- or progesterone-containing drugs
- •No prior tamoxifen for more than 1 month duration
- •No concurrent oral contraceptives or other estrogen- or progesterone-containing drugs
- •No other concurrent antiestrogen medications
- •Radiotherapy
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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