Drug Utilization Study on the Prescribing Indications for Cyproterone Acetate and Ethinyl Estradiol in 5 European Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,597
- 试验地点
- 1
- 主要终点
- Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol
研究概览
简要总结
This study was designed to compile the reasons and specific indications for the prescription of Cyproterone Acetate combined with Ethinyl Estradiol by Health Care Providers. The primary objective of the study was to characterize the prescribing behaviors for Cyproterone Acetate combined with Ethinyl Estradiol in 5 European countries (Austria, Czech Republic, France, the Netherlands, and Spain), including:
- prescription indications for Cyproterone Acetate combined with Ethinyl Estradiol
- use of Cyproterone Acetate combined with Ethinyl Estradiol in accordance with the updated label
- concomitant use of Cyproterone Acetate combined with Ethinyl Estradiol and combined hormonal contraceptives
- second line treatment with Cyproterone Acetate combined with Ethinyl Estradiol for the indication acne
详细描述
Cyproterone acetate (CPA) 2mg, in combination with ethinyl estradiol (EE) 35mcg, is a medicinal product currently indicated for the treatment of moderate to severe acne in women of reproductive age. Due to the combination with ethinyl estradiol and the dosing, the preparations also act as effective contraceptives.
In 2012, the French health authority conducted a national review of Cyproterone Acetate combined with Ethinyl Estradiol and highlighted serious thromboembolic events and extensive off-label use of these medicines as a contraceptive only. This triggered an Urgent Union Procedure at the beginning of 2013. The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) concluded that the benefits of Cyproterone Acetate combined with Ethinyl Estradiol (cyproterone acetate 2mg / ethinyl estradiol 35mcg) outweigh the risks, providing that several measures are taken to minimize the risk of thromboembolism. These medicines should be used solely for the treatment of moderate to severe acne related to androgen sensitivity and/or hirsutism in women of reproductive age. Since Cyproterone Acetate combined with Ethinyl Estradiol acts as a hormonal contraceptive, women should not take these medicines in combination with hormonal contraceptives. As one of the risk minimization measures, the Market Authorization Holders were required to conduct a number of studies including this drug utilization survey.
This study was a multi-national, cross sectional, prospective, non-interventional, drug utilization study conducted in 5 countries. Study participants were recruited by a network of health care professionals. Physicians collected information from study participants based on questionnaires. This was a one-time survey with no follow-up.
Bayer initiated this study and supported it by an unconditional grant to ZEG. Bayer was not actively involved in the study conduct.
Prolongation of recruitment:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women who are prescribed Cyproterone Acetate combined with Ethinyl Estradiol during the study period
- •Women who are willing to participate in the drug utilization study
排除标准
- •Women who are not willing to sign the informed consent
- •Women with a language barrier
结局指标
主要结局
Drug Utilization Pattern of Cyproterone Acetate and Ethinyl Estradiol
时间窗: within 18 months
Information was obtained from doctors prescribing CPA/EE. Categories in the Outcom Measure Data Table below are based on current disease status.
次要结局
未报告次要终点