Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 715
- 试验地点
- 1
- 主要终点
- Number of adverse drug reactions (ADRs)
研究概览
简要总结
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.
详细描述
It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication.
A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years.
The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment.
The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.
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
- •Patients with endometriosis-associated pelvic pain and/or dysmenorrhea.
- •Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice.
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice.
研究组 & 干预措施
BAY86-5300_YAZ-Flex
Patients with endometriosis-associated pelvic pain or dysmenorrhea
干预措施: BAY86-5300_YAZ-Flex (Drug)
结局指标
主要结局
Number of adverse drug reactions (ADRs)
时间窗: Up to 2 years ( 1 year at the earliest)
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system.
次要结局
- Incidence proportions of YAZ-Flex therapy(Up to 2 years ( 1 year at the earliest))
- Incidence proportions of extent of bleeding(Up to 2 years ( 1 year at the earliest))
- Incidence proportions of treatment suspension(Up to 2 years ( 1 year at the earliest))
- Number of days with menstrual pain(Up to 2 years ( 1 year at the earliest))
- Number of date of using analgesic(Up to 2 years ( 1 year at the earliest))
- Change in severity of dysmenorrhea(Up to 2 years ( 1 year at the earliest))
- Change in severity of pelvic pain by using Numeric Rating Scale (NRS)(Up to 2 years ( 1 year at the earliest))
- Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ(Up to 2 years ( 1 year at the earliest))