NCT00874653已完成不适用
Levonorgestrel Releasing Intrauterine System (MIRENA) in Idiopathic Menorrhagia
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 78
- 主要终点
- The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
研究概览
简要总结
The purposes of this study are:
- To evaluate patient satisfaction for efficacy and tolerability of heavy menstrual bleeding treatment by Mirena.
- To collect italian data for Mirena in clinical routine.
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
- 30 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer than three months according to the assessment of the investigator and according to the international and national guidelines. These women should also accept to be on contraception during the time period that they have Mirena in situ
- •Body Mass Index = 18-30
排除标准
- •One or more of the following disorders: Current or recurrent pelvic inflammatory disease; infection of the lower genital tract; postpartum endometritis; septic abortion during the past three months; cervicitis; cervical dysplasia; uterine or cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired abnormality of the uterus including fibroids if they distort the uterine cavity; conditions associated with increased susceptibility to infections; acute liver disease or liver tumor; known hypersensitivity to any of the constituents of the product
- •Nulliparity
- •Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could effect bleeding should be stopped at least 3 months before the first visit and should not be used during the course of the study.
- •History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
- •Anticoagulation therapy
- •Cancer history including breast cancer
研究组 & 干预措施
Group 1
干预措施: Levonorgestrel (Mirena, BAY86-5028) (Drug)
结局指标
主要结局
The quality of life on the basis of the validated Health-Related Quality of Life questionnaire (HRQL SF-36)
时间窗: at 12 months
次要结局
未报告次要终点
研究者
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