A Multicenter，Prospective Clinical Trial for Reducing Remaining Submucous Fibroids Volume and Preventing Recurrence by Treating With GnRH Analogues or Mifepristone After Transcervical Resection of Type I-II Myoma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- the remaining submucous fibroids volume
研究概览
简要总结
Transcervical resection of myoma(TCRM) has a good therapeutic effect while the probability of complete resection of type I and II fibroids is only 55% per procedure on average and a significant number of patients have fibroid remained.At present, there is no standardized treatment option for reducing the remaining submucous fibroids volume and preventing its recurrence after TCRM.The present prospective,multicentre,randomised controlled clinical trial will enrol women after TCRM and treat them with mifepristone(10mg)or GnRHa(3.60mg)for 3 to 6 months,investigating the effective and cost-effective treatment options after fibroids with TCRM，thus to provide evidence and effectual regiments for reducing remaining fibroids volume and preventing its recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years and less than 45 years old, no childbirth requirements in the next 3 years;
- •Type I and II submucosal fibroids diagnosed by ultrasound, and the diameter of them are greater than 3cm;
- •Type I or II submucosal fibroids confirmed by TCRM and no degeneration confirmed pathologically;
- •A MRI test will be done to evaluate the residual submucosal fibroids and calculate the residual fibroid volume after 1 month of surgery;
- •Patients would not had used drugs such as mifepristone and GnRHa 3 months before surgery;
- •Participate in this trial and sign the informed consent form voluntarily .
排除标准
- •Combined with congenital uterine malformations such as double uterus, unicornuate uterus, etc;
- •Have fertility requirements within 3 years after surgery;
- •Estrogen-dependent diseases such as adenomyosis and endometriosis;
- •Drugs such as mifepristone or GnRHa have been used before surgery;
- •Mifepristone or GnRHa drug treatment is contraindicated or cannot tolerate TCRM surgery.
研究组 & 干预措施
GnRHa group
Patients with fibroid remained will be enrolled and one third of them will be administrated with Zoladex (3.60mg/28 days) for three to six months,.
干预措施: Zoladex (Drug)
mifepristone group
Patients with fibroid remained will be enrolled and one third of them will be administrated with mifepristone(10.0mg/d) for three to six months.
干预措施: Mifepristone Oral Tablet (Drug)
结局指标
主要结局
the remaining submucous fibroids volume
时间窗: one to three years after TCRM
The change of residual fibroid volume is compared to residual fibroid volume measured by ultrasound and /or MRI one month after surgery;
次要结局
- the recurrence rate of remaining submucous fibroids and time(one to three years after TCRM)
- the recurrence time of remaining submucous fibroids(one to three years after TCRM)