Drug Utilization Study on Diane®-35 (and Generics) in European Healthcare Databases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 26,065
- 主要终点
- Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
研究概览
简要总结
The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of ≥ 365 days prior to index date will be included in the study.
排除标准
- •<365 days recorded history in the database prior to index date
- •a prescription of CPA/EE in the year prior to index date
研究组 & 干预措施
Drug Utilisation / Cohort 1
New users of CPA/EE in 2011/2012 and in 2014
干预措施: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics (Drug)
结局指标
主要结局
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
时间窗: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)
时间窗: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism
时间窗: up to 12 months
次要结局
- Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives(up to 12 months)
- Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.(up to 12 months)