Study to Characterize Patients Treated With Visanne for Their Endometriosis Under Real-life Practice Conditions and Evaluate Their Quality of Life at Baseline and After 6 Months of Treatment With Visanne.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,006
- 主要终点
- Percentage of patients, who show an improvement of the EHP-5 items
研究概览
简要总结
The study aims to collect data on the influence of a treatment with Visanne (Dienogest 2mg/d) on the Endometriosis related quality of life. These data will be collected using a special patient questionnaire (Endometriosis Health Profile 5, EHP-5). The study will also be used to describe the basic disease status and demographic characteristics of patients searching treatment by a gynecologist because of their endometriosis. In addition, the study will give insight into the typical diagnostic measures the physicians in different countries are using in the field of endometriosis.
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
- •Female patients older than 18 years of age
- •Clinical or laparoscopic diagnosis of endometriosis
- •Having endometriosis related pain as leading symptom
- •Decision taken by physician to prescribe Visanne
- •Signed Informed Consent Form
排除标准
- •Contraindications listed in the local summary of product characteristics (SPC) have to be considered.
研究组 & 干预措施
Group 1
干预措施: Visanne (Dienogest, BAY86-5258) (Drug)
结局指标
主要结局
Percentage of patients, who show an improvement of the EHP-5 items
时间窗: after 6 months of treatment
Mean changes of EHP-5 items by using scores for pre-defined categories
时间窗: after 6 months of treatment
次要结局
- Baseline demographic characteristics and disease status of patients with endometriosis treated with Visanne(Baseline)
- Reasons for treatment discontinuation(after 6 months of treatment)
- Safety variables will be summarized using descriptive statistics based on adverse events collection(after 6 months of treatment)
- Patient reported severity of endometriosis related pain(Baseline and after 6 months of treatment)