临床试验/NCT01414140

NCT01414140已完成不适用

Drug Use Investigation of Mirena

Bayer0 个研究点目标入组 567 人开始时间: 2007年5月最近更新: 2014年1月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Bayer
入组人数: 567
主要终点: Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of women who are inserted Mirena for intrauterine contraception. The objective of this study is to assess safety and effectiveness of Mirena under real-life practice conditions. A total 550 patients will be recruited and followed for 5 years.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: Female
接受健康志愿者: 否

入选标准

•Women who are inserted Mirena for intrauterine contraception

排除标准

•Women who are contraindicated based on the product label

研究组 & 干预措施

Group 1

干预措施: Levonorgestrel IUS (Mirena, BAY86-5028) (Drug)

结局指标

主要结局

Incidence of adverse drug reactions and serious adverse events in women who are inserted Mirena

时间窗: After Mirera insertion, up to 5 years

Incidence of adverse drug reactions, especially Pelvic inflammatory disease in women who are inserted Mirena

时间窗: After Mirera insertion, up to 5 years

次要结局

Incidence of adverse drug reactions in subpopulation in a variety of baseline data (such as demographic data, concomitant disease) and duration of Mirena(After Mirera insertion, up to 5 years)
Released amount of Levonorgestrel [estimated from removed Mirena](After Mirera insertion, up to 5 years)
Pregnancy rate(After Mirera insertion, up to 5 years)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

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