A Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
A Placebo Controlled Study on the Efficacy of 10 mg Oral Mifepristone for the Treatment of Symptomatic Uterine Leiomyomas
The first indication of hysterectomies in France are uterine leiomyomas. When they are symptomatic leiomyomas are particularly responsables of an increase of menstruations duration and volume. Echography is the reference exam for the diagnosis. It exists two treatments ways:-firstly progestatives and antifibrinolytics for the treatment of hemorragic symptoms, -secondly LH-RH analogs for the treatment of leiomyomas volume and hemorragic symptoms but just used for a small period because of the risk of osteoporosis.
Different studies with different doses of mifepristone were released. The authors observe a decrease of leiomyomas volume. Based on this experience the present placebo controlled study has for objectives:-to confirm the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease and in symptoms of leiomyomas, - to assess the safety of the treatment. The aim is to avoid or delay the hysterectomy of non menopausal patients. During the study patients will be evaluated with biological exams, clinical exams, echographies, medical interrogations and their diary cards.
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Poitiers、法国、86000
- Poitiers University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients who are willing and able to participate in the study
- patients from whom written informed consent has been obtained
- patients who contribute to the National Insurance Scheme
- patients with an age between 25 and 49 years old
- non menopausal patients
- patients who use a non hormonal contraception
- patients with one or several , interstitial or subserous, uterine leiomyomas
- echographic diameter of leiomyomas must be equal or higher than 30 mm
- leiomyomas must be symptomatic
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
研究衡量的是什么？
主要结果指标
结果测量 |
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To determine the efficacy of 10 mg oral mifepristone during 24 weeks in the volume decrease of symptomatic uterine leiomymomas
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次要结果测量
结果测量 |
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-To determine the efficacy of 10 mg oral mifepristone in symptoms of non menopausal patients with uterine leiomyomas
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-To determine the safety of oral mifepristone at the dose of 10 mg per day during 24 weeks
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合作者和调查者
调查人员
- 首席研究员：Guillaume Magnin, Professor、Poitiers University Hospital
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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