NCT01200186已完成不适用
Non-interventional Study on Oral Contraception Not Containing Ethinylestradiol (EE) to Assess Continuation Rates and Satisfaction
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
- 3,258
- 主要终点
- The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
研究概览
简要总结
Prospective, non-interventional, multi-center study. Each subject will be followed for up to twelve months during the treatment with oral hormonal contraceptives(Qlaira ® or a Progestin Only Pill). For each subject demographic data and medical history will be documented at Visit 1: (Baseline). Bleeding profile, subjective assessment of study treatment (satisfaction and wellbeing) and adverse events including unintended pregnancies will be documented at Visit 2 (Month 3-5) and Visit 3 (Month 6-12). Data audit/monitoring will be done.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women between 18-50 years
- •Women who used ethinylestradiol containing oral contraceptives for at least the three preceding months before the study
- •Women who decided to start Qlaira® or a Progestin Only Pill. The prescription of the hormonal contraceptive is made at the discretion of the attending physician and has to be documented
排除标准
- •Contraindications and warnings of the respective Summary of Product Characteristics (Qlaira® or Progestin Only Pill)
- •Women who are breast-feeding
研究组 & 干预措施
Group 1
干预措施: EV/DNG (Qlaira, BAY86-5027) (Drug)
Group 2
干预措施: Progestin Only Pills (Drug)
结局指标
主要结局
The primary outcome measure will be time-to-event for discontinuation due to bleeding irregularities.
时间窗: up to 12 Months
次要结局
- Number of heavy and/or prolonged bleeding(Month 6-12)
- Number of intracyclic bleeding(Month 6-12)
- Global assessment of well-being and satisfaction(Month 6-12)
- Adverse events (AEs) at any time point, whether or not related to the therapy or reference therapy(up to 12 Months)
- Time to event for discontinuation due to reasons other than bleeding irregularities(Month 6-12)
- Number of unintended pregnancies(Month 6-12)
- Discontinuation rate for the following reasons: Occasional absent or persistent absent withdrawal bleeding , intracyclic bleeding, heavy and/or prolonged bleeding, other medical reasons, non-medical reasons(Month 6-12)
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