EUCTR2012-000406-29-NL进行中(未招募)不适用
The influence of morning versus evening administration on tamoxifen pharmacokinetics - Morning versus evening administration of tamoxifen
未提供0 个研究点目标入组 18 人开始时间: 2012年3月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •-Histological or cytological confirmed diagnosis of breast cancer, for which treatment with tamoxifen is indicated (to be evaluated by the treating physician);
- •-Use of tamoxifen for at least 4 weeks and willing to continue the treatment until the end of the study;
- •-Age > 18 years;
- •-WHO performance = 1;
- •-Written informed consent;
- •-Adequate renal and hepatic functions;
- •-Adequate hematological blood counts;
- •-No chemotherapy within the last 4 weeks before start;
- •-No radiotherapy within the last 4 weeks before start.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Pregnant or lactating patients;
- •-Serious illness or medical unstable condition requiring treatment, symptomatic CNS metastases or history of psychiatric disorder that would prohibit the understanding and giving of informed consent;
- •-More than one dose of tamoxifen (20 or 40 mg) per day;
- •-Non-compliance.
研究者
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