NCT01797809已完成不适用
Qlaira® 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
- 757
- 主要终点
- Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
研究概览
简要总结
The objective of this PMS is to gain information about safety and efficacy in real practice as a regulatory commitment required by KFDA (Korea Food and drug administration)
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 after menarche and before menopause
- •Women requesting contraception or Women diagnosed by a physician as having HMB due to non-organic cause who are also requesting contraception
- •Women who are prescribed Qlaira® 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: EV/DNG (Qlaira, BAY86-5027) (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) including serious adverse events (SAEs) and Adverse Drug Reactions (ADRs)
时间窗: Up to 6 months
次要结局
- Contraceptive Efficacy by Number of unintended pregnancies(From 3 to 6 months)
- Contraceptive Efficacy by Compliance with Qlaira taking : Administered tablet number/prescribed tablet number(From 3 to 6 months)
- The relief of heavy menstrual bleeding symptom also will be calculated as an efficacy variable from admission to the study until final visit by subject's assessment(From 3 to 6 months)
- Number of subjects with improved heavy menstrual bleeding(From 3 to 6 months)
研究者
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