NCT00696202已完成4 期
A Multicentre, Open Label, Uncontrolled Study of the Tolerance, Acceptability and Contraceptive Efficacy of Mirena 52 mg®, an Intra-uterine Levonorgestrel Device, During the First Year After Insertion Post-partum
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
- 199
- 主要终点
- Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
研究概览
简要总结
In this trial the efficacy and safety of Mirena was investigated during the first year of use
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
- 25 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women aged 25 to 39 years who sought effective contraception during the post-partum period (i.e. insertion of the device between 6 and 12 weeks after parturition).
排除标准
- •Standard exclusion criteria for use of intrauterine hormone devices
研究组 & 干预措施
Arm 1
Experimental
干预措施: Mirena (BAY86-5028) (Drug)
结局指标
主要结局
Adverse event related to the product causing a subject to withdraw, or be withdrawn, from the study at any time up to 12 months from the insertion of Mirena
时间窗: within 12 months after randomization
次要结局
- General safety assessment(within 12 months after randomization)
研究者
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