NCT03182140已完成不适用
KYleena Satisfaction Study / Observational Study on User Satisfaction With the Levonorgestrel Intrauterine Delivery System Kyleena (LNG-IUS 12) in New Contraceptive Users and After Switching From Another Contraceptive Method
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
- 1,134
- 试验地点
- 13
- 主要终点
- Overall satisfaction with Kyleena assessed by questionnaire
研究概览
简要总结
The main goal of this non-interventional study (NIS) is to evaluate user satisfaction with Kyleena in a real-life setting and to identify factors which influence user satisfaction, taking into account previously used contraceptive methods and reasons for use of Kyleena.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women requesting contraception with Kyleena. The woman's informed decision for contraception with Kyleena was made before and independently from the study as per investigator's routine practice
- •Written informed consent.
排除标准
- •Contraindications for Kyleena according to the local market authorization/SmPC
- •Mental incapacity to consent and provide data during the observational study
- •Women participating in an investigational program with interventions outside of routine clinical practice.
研究组 & 干预措施
Kyleena
Non-interventional, observational, uncontrolled study in women that have chosen Kyleena as their contraceptive method before entering the study
干预措施: Kyleena (Drug)
结局指标
主要结局
Overall satisfaction with Kyleena assessed by questionnaire
时间窗: approximately at 12 months after insertion or at premature discontinuation
The rating is based on the 5-item Likert scale (very satisfied, satisfied, neither satisfied nor dissatisfied, dissatisfied, very dissatisfied).
次要结局
- Ease of insertion assessed by investigator(Day 1)
- Pain at insertion assessed by participant(Day 1)
- Overall satisfaction with Kyleena assessed by questionnaire(approximately 4-12 weeks after insertion)
- Satisfaction with the menstrual bleeding profile with Kyleena assessed by questionnaire(after approximately 12 months or at premature discontinuation and approximately 4-12 weeks after insertion)
研究者
研究点 (13)
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