临床试验/NCT00798980

NCT00798980已完成不适用

Scandinavian Mirena Insertion Nulliparous Trial of an Observational Study.

Bayer0 个研究点目标入组 224 人开始时间: 2007年2月最近更新: 2015年4月22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: 224
主要终点: Evaluation of the insertion procedure of Mirena in nulliparous women

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

In this non-interventional study we investigate the nulliparous women individual evaluation of the insertion procedure of LNG-IUD and the follow-up period of 3 months post insertion.

研究设计

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

入排标准

年龄范围: 14 Years 至 —（Child, Adult, Older Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Nulliparous women Mirena insertion planned as contraceptive method

排除标准

•Ongoing or suspected pregnancy;
•Ongoing or recidivating genital infection;
•Cervicitis;
•Cervical dysplasia;
•Malignancy in uterus or cervix;
•Confirmed or suspected hormone sensitive neoplasia including breast cancer
•Undiagnosed abnormal uterine bleeding;
•Uterine anomaly including myoma if the cavity of the uterus is restricted;
•Conditions that cause increased risk of infections;
•Acute liver disease or liver tumour;
•Allergy to the active substance or any component of the IUD

研究组 & 干预措施

Arm 1

干预措施: Mirena (BAY86-5028) (Drug)

结局指标

主要结局

Evaluation of the insertion procedure of Mirena in nulliparous women

时间窗: At the insertion time point

次要结局

Continuation rate(12-16 weeks post insertion)
Pain(At the insertion time point)
Bleeding Pattern(12-16 weeks post insertion)
Satisfaction(12-16 weeks post insertion)

研究者

发起方

Bayer

申办方类型

Industry

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