VISANNE OS/Treatment of Endometriosis With Dienogest in the Real World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 968
- 试验地点
- 1
- 主要终点
- The absolute number of AEs reported with Visanne treatment
研究概览
简要总结
Endometriosis is a condition that affects women, usually during their reproductive years. In women with endometriosis, the tissue that lines the uterus starts to grow outside of the uterus. This can cause pain during their periods or during sex, and constant pain in the pelvis. Endometriosis can decrease a woman's quality of life and requires long-term treatment to control the symptoms.
For some women with endometriosis, symptoms can return after they stop treatment. Or, they may not be able to tolerate the current long-term treatment options.
In this study, researchers will find out more about the safety of long-term treatment with dienogest in a large number of Chinese participants. This study will enroll patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis. All of the participants will take dienogest based on their doctor's instructions. They will then visit their doctor's office 3 times over 6 months. During these visits, their doctors will ask them if they have any health problems and about their quality of life. Their doctors will also do tests to measure the pain caused by their endometriosis and any other symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Post-menarcheal age through menopause.
- •Have clinically or surgically diagnosed endometriosis according to routine clinical practice.
- •Decision for the treatment with Visanne was made as per physician's routine treatment practice.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
- •Any contraindication according to Visanne Chinese label
研究组 & 干预措施
Visanne treatment
Patients from post-menarche to menopause with clinically or surgically diagnosed endometriosis, who have been prescribed Visanne
干预措施: Dienogest (Visanne,BAY86_5258) (Drug)
结局指标
主要结局
The absolute number of AEs reported with Visanne treatment
时间窗: From baseline up to 6 months
AE: Adverse Event
The proportion of AEs reported with Visanne treatment
时间窗: From baseline up to 6 months
Proportion of each AE will be calculated as number of patients with at least one event divided by the total number of patients.
The absolute number of ADRs reported with Visanne treatment
时间窗: From baseline up to 6 months
ADR: Adverse drug reaction
The proportion of ADRs reported with Visanne treatment
时间窗: From baseline up to 6 months
Proportion of each ADR will be calculated as number of patients with at least one event divided by the total number of patients.
次要结局
- Changes in Numeric Rating Scale (NRS) score of Endometriosis Associated Pelvic Pain (EAPP) of Visanne treatment(From baseline up to 1,3,6 months)
- Endometriosis Health Profile-5 (EHP-5) score changes with Visanne treatment(At baseline and 6 months.)
- The proportion of participant with amenorrhea, infrequent bleeding, frequent bleeding irregular bleeding, prolonged bleeding upon treatment with Visanne(At baseline, 1, 3, and 6 months)
- Changes in Clinical Global Impression (CGI) scale scores of overall symptom development(At 3 and 6 months)
- Changes in Patient Global Impression (PGI-C) scale scores of overall symptom development(At 3 and 6 months)
- Reasons for discontinuation of using Visanne(From baseline up to 6 months)
- Patient and physician's satisfaction score on Visanne® treatment(At 3 and 6 months)