Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 759
- 主要终点
- The knowledge of the physician concerning Diane-35
研究概览
简要总结
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.
Specifically, the following objectives will be addressed:
- Investigate whether physicians have received any educational material related to Diane-35 or its generics
- Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
- Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
- Contraindications relevant to thromboembolism
- Risk factors for thromboembolism
- Signs and symptoms of thromboembolism
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
排除标准
- 未提供
研究组 & 干预措施
Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey
干预措施: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35) (Drug)
结局指标
主要结局
The knowledge of the physician concerning Diane-35
时间窗: Day1
The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist
次要结局
未报告次要终点