NCT00868153已完成不适用
Levonorgestrel Releasing Intrauterine Device (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
- 1,125
- 主要终点
- To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
研究概览
简要总结
This is an open-label, uncontrolled, multi-centre observational study that analyses a follow-up of 1600 women with dysfunctional uterine bleeding (idiopathic menorrhagia) over a period of one year.The patients evaluated at four visits, beginning with the insertion visit and 3, 6 and 12 months after 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
- 30 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman diagnosed with idiopathic Menorrhagia according to assessment of the investigator and according to international guidelines. These woman should also accept to be on contraception during the time period that they have Mirena in situ.
- •Age limit 30-45
- •BMI= 18-34
- •Signed informed consent
排除标准
- •Medical conditions featured in the Mirena data sheet (See Appendix 1) that contraindicate its use, listed below:
- •Known or suspected pregnancy; 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 IUS (Mirena , BAY86-5028) (Drug)
结局指标
主要结局
To evaluate the improvement in the quality of life and the degree of satisfaction of women with idiopathic menorrhagia treated with Mirena
时间窗: At vist 1 and 4
次要结局
- Information about the pattern of menstrual bleeding recorded in an ongoing way throughout the duration of the study(Every visit)
- The health-related quality of life questionnaire SF-36 at Visits 1 and 4(Visit 1 and 4)
- The user satisfaction as recorded at Visit 4(visit 4)
- Adverse reactions recorded in an ongoing way throughout the duration of the study(every visit)
- Laboratory parameters as measured at Visits 1 and 4(visit 1 and 4)
研究者
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