NCT01788722已完成不适用
Visanne® (Dienogest 2mg) Regulatory Post Marketing Surveillance Study in Korea
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 3,223
- 主要终点
- Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
研究概览
简要总结
The objective of the study is to investigate and collect post marketing data on the safety and efficacy of Visanne at follow-up visit after about 6 months of treatment and - for a subset of patients - at optional long-term follow-up visit after about 1 year of treatment under daily practice treatment conditions in Korean women and to obtain data on drug utilization on treatment for endometriosis.
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 and dated informed consent
- •Women diagnosed by a physician as having endometriosis
- •Women who are prescribed Visanne(dienogest 2mg)for the first time during the study period
排除标准
- •All contraindications according to the local marketing authorization have to be considered.
研究组 & 干预措施
Group 1
干预措施: Dienogest (Visanne, BAY86-5258) (Drug)
结局指标
主要结局
Number of participants with adverse events( AE) and Serious adverse events(SAE) as a measure of safety and tolerability
时间窗: up to 1 year
次要结局
- Changes of relief of endometriosis-associated pelvic pain (EAPP) will be measured on VAS for total study population(6 months and 1 year)
- Evaluation of VAS score changes for sub analysis( In case of VAS score≥ 30mm in initial visit).(6 months and 1 year)
研究者
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