NCT01590537已完成不适用
Prospective Multicentre Non-interventional Comparative Study of Long-term Intrauterine Contraceptives Acceptability and User 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
- 2,348
- 主要终点
- User satisfaction of the contraception method with Mirena or Copper IUD
研究概览
简要总结
This is local prospective, non-interventional multi-center comparative study. Primary study objective is evaluation of the user satisfaction with Mirena or Copper IUD up to 1 year after insertion ( patient assessment questionnaire) in daily practice. For each patient, the treating gynecologist documents demographics, medical data, safety parameters and treatment signs and symptoms at an initial visit and one or two follow-up visit(s).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 20-40 years old
- •Parity ≥ 1 child
- •Requesting long-term contraception
- •Written informed consent.
排除标准
- •in accordance with the current leaflet
研究组 & 干预措施
Group 1
干预措施: Levonorgestrel (Mirena, BAY86-5028) (Drug)
Group 2
干预措施: Copper IUD (Device)
结局指标
主要结局
User satisfaction of the contraception method with Mirena or Copper IUD
时间窗: up to 12 months
次要结局
- Continuation/discontinuation rate ( number of cases with contraceptive method continuation and discontinuations)(up to 12 months)
- Safety evaluation of Mirena or Copper IUD in routine practice Safety parameters include number of AEs, severity,relationship to Mirena or Cooper IUD(up to 12 months)
- Relationship between different parameters and women preferences in choosing Mirena or Cooper IUD as their contraceptive method ( demographic parameters, age group, residence, reproductive history and plans, etc.) using patients questionnaire(up to 12 months)
- Contraceptive reliability of Mirena or Cooper IUD in routine practice ( fixing number of pregnancies)(up to 12 months)
研究者
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