临床试验/NCT01833793

NCT01833793已完成不适用

Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion

Bayer0 个研究点目标入组 35 人开始时间: 2013年2月最近更新: 2015年9月14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: 35
主要终点: Proportion of Mirena users who have at least one period of Amenorrhea of at least three months

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

MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.

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: 18 Years 至 40 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Age 19-40 years at the time of Mirena IUD insertion
•Using Mirena only for contraception indication
•Never having used the product before
•No heavy menstrual bleeding diagnosed
•Have signed informed consent to participate in this study

排除标准

•Nulliparous
•Pregnancy
•Mirena's contre-indication
•Mirena for HMB
•Abnormal bleeding pattern

研究组 & 干预措施

Group 1

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

结局指标

主要结局

Proportion of Mirena users who have at least one period of Amenorrhea of at least three months

时间窗: 12 months

Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users

时间窗: 12 months

次要结局

Proportion of Mirena users with menorrhagia(12 months)
Cumulative rate of satisfaction in Mirena users(12 months)
Proportion of Mirena users who have menstrual disorders(12 months)

研究者

发起方

Bayer

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

MIRENA for Contraception In InDian Subjects User continuAtion and Satisfaction Study: MIDAS StudyContraception

NCT01961375Bayer600

已完成

4 期

A Study Comparing Mirena and Systemic Progestin for Endometrial HyperplasiaEndometrial Hyperplasia

NCT01074892University Hospital of North Norway170

已完成

不适用

Mirena or Conventional Medical Treatment for MenorrhagiaMenorrhagia

NCT00864136Bayer647

已完成

不适用

MiCo - Mirena or Conventional Medical Treatment for MenorrhagiaIdiopathic Menorrhagia

NCT01085487Bayer1,211

已完成

3 期

Mirena Extension TrialContraception

NCT02985541Bayer364