Efficacy and Safety of Rapamycin (Sirolimus) in the Treatment of Symptomatic Uterine Fibroids and Leiomyomatosis
试验速览
- 阶段
- 4 期
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- size of uterus and the myoma
研究概览
简要总结
A prospective non-randomized open label clinical trial to research the efficacy and safety of sirolimus in patients with symptomatic, recurrent uterine fibroids or/and various rare leiomyoma.
详细描述
Recent studies indicate that mTOR pathway is a specific and sensitive tumor target molecule in uterine fibroids, which can be used as a target molecule for interventional therapy and can provide a new cut-in point for nonoperative treatment. However, the application of mTOR inhibitor (sirolimus) in the treatment of uterine fibroids remains blank. Our study was designed as a prospective non-randomized open label clinical trial to research its efficacy and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
rapamycin
rapamycin, 2 mg a day, orally ,for 3months
干预措施: rapamycin (Drug)
结局指标
主要结局
size of uterus and the myoma
时间窗: 2 day
efficacy assessment
次要结局
- hormone levels(2 day)
- menstrual blood volume / haemorrhage(1 day)
- adverse event(2 day)
- follicular size(2 day)
研究者
zhulan
professor
Peking Union Medical College Hospital