EffectiveNess of VISanne® in Improving Quality of Life in asIan wOmen With eNdometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 895
- 主要终点
- The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months.
研究概览
简要总结
This study is a prospective observational cohort study. The study will be conducted in routine clinical practice settings. It is planned to enroll 870 patients with endometriosis for whom a decision has been made by the physician to treat with dienogest according to local health authority approved label. It is the aim of this observational cohort study to further characterize the effectiveness of dienogest in improving quality of life and long-term safety in routine clinical practice setting. Endometriosis is chronic and progressive disease and there is unmet need for long-term treatment. Visanne® with proven efficacy and safety, can be good option for long-term treatment, however, experience with Visanne® beyond 15 month is limited. And long-term up to 24 months data on effectiveness and safety of Visanne would support the long-term treatment strategy for Endometriosis management in the clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Asian Female patients at least 18 years of age
- •Clinical or surgical diagnosis of endometriosis (depending on local approved indication) : Clinical diagnosis by suggestive symptoms and positive finding in imaging study (Chocolate cyst)
- •Patients with Endometriosis associated pelvic pain
- •Decision taken by the physician to newly prescribe Visanne®
- •Availability of a signed informed consent
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Patients for whom any of contraindication listed in the local summary of product characteristics (SPC) apply.
研究组 & 干预措施
Cohort 1
Asian patients at least 18 years of age with clinical or surgical diagnosis of endometriosis, and patients with endometriosis associated pelvic pain.
干预措施: Dienogest (Visanne, BAY86-5258) (Drug)
结局指标
主要结局
The mean change from baseline to 24 months of treatment in pain-related Quality of Life measured by EHP-30 for patients who continue to take Visanne up to 24 months.
时间窗: Baseline and to 24 months
The mean change from baseline to 6 months of treatment in pain-related Quality of Life measured by EHP-30.
时间窗: Baseline and at 6 months
次要结局
- Patient and physician's satisfaction score on Visanne® treatment(At 6 months, 12 months, 24 months)
- Proportion of subjects who continue treatment with Visanne®(At 6 months, 12 months, 24 months)
- Reasons for stopping of treatment with Visanne®(At 6 months, 12 months, 24 months)
- Proportion of patients with amenorrhea, intermenstrual bleeding/spotting or irregular bleeding while treatment with Visanne®(At 1 month, 3 months, 6 months, 12 months, and 24 months)
- Mean change from baseline to 6 months and baseline to 24 months of treatment in other domain of Quality of life measured by EHP-30(Baseline and 6 months,Baseline to 24 months)
- Mean change of Endometriosis-associated pelvic pain (EAPP) from baseline in patients with endometriosis either surgically or clinically diagnosed.(Baseline and 6 months, Baseline and 12 months, Baseline and 24 months)
- Proportion of patients who experienced pain recurrence in patients taking Visanne up to 24 months(Up to 24 months)
- Time point for first pain recurrence after stopping taking Visanne and before to start any treatment.(Up to 24 months)
- Proportion of patients who underwent repeated surgery in patients taking Visanne up to 24 months(Up to 24 months)
- Proportion of patients who underwent repeated surgery between stopping Visanne treatment and starting any other treatment than surgery(Up to 24 months)
- Patient's assessment of overall symptom development using the Clinical Global Impression (CGI) scale(At 6 months, 12 months, 24 months)