Monitoring Tolerance, Safety and Acceptance of Depo-Eligard® in an Open Label, Retrospective, Non-interventional Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
研究概览
简要总结
Study will evaluate the real-world effectiveness of Depo-Eligard® after six months of treatment
详细描述
The study will provide data on the tolerance, safety and acceptance of Depo-Eligard® (leuproreline acetate) when used in routine clinical practice. Data on efficacy parameters such as testosterone, PSA levels, symptoms and treatment failure, if available will be collected.It will reflect the way Depo-Eligard® is used in routine clinical practice and how PSA, testosterone levels, symptoms and treatment failure, are used as parameters in the treatment for Prostate Cancer.
Patient data will be collected after a treatment period of six months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients having been prescribed Depo-Eligard® in accordance with the terms of the marketing authorization
- •Patients on treatment with Depo-Eligard® for at least six months
- •Written consent has been obtained
排除标准
- 未提供
结局指标
主要结局
Tolerance, Safety (Adverse drug reactions, overall evaluation of safety and tolerability) and Acceptance of Depo-Eligard®
时间窗: After at least 6 months treatment with Depo-Eligard
次要结局
- Measurement of PSA and testosterone levels if available(After at least 6 months treatment with Depo-Eligard)
- Overall evaluation of efficacy(After a least 6 months treatment with Depo-Eligard)
- Overall patient assessment of treatment benefit(After at least 6 months treatment with Depo-Eligard)