The Effect of Preoperative Treatment With Mifepristone on Uterine Fibroids and Breast Tissue
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Myoma size
研究概览
简要总结
Uterine fibroids are a benign but common condition among women in reproductive age. It is one of the most common reasons for hysterectomy since it often causes bleeding problems sometimes leading to anemia. Several alternative treatment regimens have been investigated that could replace surgery. The antiprogesterone, mifepristone, is one of the most promising drugs that have been tested. In addition to the inhibiting effect on the growth of uterine fibroids antiprogestins have been proposed to have an antiproliferative effect on breast tissue.
The purpose of the present study is to evaluate the effect of mifepristone on the volume of uterine fibroids. The study will also address the effect of mifepristone on the breast tissue
详细描述
Other purposes of this study include:
- To develop a new non-surgical method for treatment of uterine fibroids
- To study the effect of mifepristone on the size of uterine fibroids
- To evaluate factors regulating fibroid growth by comparison with untreated fibroids and normal myometrium
- To study the effect of mifepristone on the amount of blood loss and pelvic pain in patients with fibroids
- To study the effect of mifepristone on proliferation of breast tissue
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uterine fibroids requiring treatment
- •Good general health
- •Willing and able to participate after giving informed consent
排除标准
- •Need for immediate surgery
- •Concomitant hormonal treatment (HRT)
- •History of malignant disorder of the breast
- •Any contraindication for mifepristone
- •Criteria for retrospective exclusion:
- •Subjects may be excluded from analysis if one of the following applies:
- •Any violation of the study protocol
- •Lack of essential data
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
I
Mifepristone (Mifegyne) 50 mg every other day for 3 months
干预措施: Mifegyne (Drug)
结局指标
主要结局
Myoma size
时间窗: 2004 to 2007
次要结局
- Breast epithelial cell proliferation(2004 to 2007)