NCT00498784已完成4 期
A Multicenter, Open Labelled, Uncontrolled, Phase IV Clinical Study to Evaluate the Health-related Quality of Life and Sexual Well-being in Young (18-35) Healthy Mirena Users Switching From OC, Over the First Year Post-insertion.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 141
- 主要终点
- Health-related QoL score
研究概览
简要总结
The purpose of this study is to evaluate the changes in the quality of life, as well as in the sexual activity, in women inserted with MIRENA, a hormonal contraceptive intra-uterine system, over the first 12 months of use. Patients switching from oral contraception to an intrauterine contraceptive device (here: MIRENA) will be observed in the first year post MIRENA insertion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy woman willing to, or having to switch from her OC to another contraceptive method
排除标准
- •Any contraindication to Mirena insertion/use
研究组 & 干预措施
Arm 1
Experimental
干预措施: Mirena (Drug)
结局指标
主要结局
Health-related QoL score
时间窗: 1 year
次要结局
- Sexuality Index, treatment satisfaction, usual safety outcomes(1 year)
研究者
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