Effects of Counseling on the Continuation Rates and Compliance for Newly Prescribed Oral Contraceptives (Yasmin® or Any Other Oral Contraceptives (OC))
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 5,446
- 主要终点
- Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
研究概览
简要总结
This study is a prospective, company-sponsored, non-interventional cohort study of up to 5000 patients in European countries and countries in Middle East who are newly prescribed any available OC. Patients will be followed up approximately 6 months after initial visit. Selection of Study Population: Women can be enrolled after decision for treatment with Yasmin or any other OC has been made. Physicians should consult the full prescribing information for the respective OC before enrolling patients and familiarize themselves with the safety information in the product package label.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who have been found eligible for OC use and have newly been prescribed an OC in accordance with the terms of the respective marketing authorization
- •Starter (first-ever user of an OC) and switcher from another OC (incl. women with a history of OC use)
排除标准
- •The contraindications and warnings of the Summary of Product Characteristics must be followed.
研究组 & 干预措施
Group 1
干预措施: EE30/DRSP (Yasmin, BAY86-5131) (Drug)
Group 2
干预措施: Any other OC (Drug)
结局指标
主要结局
Analyses of continuation rates and compliance stratified by the subject's knowledge on the respective topics and time spent for counseling.
时间窗: After 3 months and at end of study after approx. 6 months.
次要结局
- Analyses stratified by baseline factors such as age group, presence or absence of cycle disorders, and history of oral contraceptive method will be performed as well.(After 3 months and after approx. 6 months.)
- Special attention will be paid to serious adverse events and unexpected or unlisted ADRs.(Over 12 months)