The Effect of Vaginal Mifepristone on Reduction of Uterine Fibroids Size and the Symptoms Associated With the Fibroids - Pilot Study (Phase IIa)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Decrease of uterine fibroids volume by 25% and up.
研究概览
简要总结
The purpose of this study is to evaluate the effect of daily dosage of vaginally mifepristone on reduction of uterine fibroids size and the symptoms associated with uterine fibroids.
详细描述
Uterine fibroids are benign tumors of the uterus made up of smooth muscle and the extracellular matrix proteins Collagen and Elastin. They are exceptionally common; the cumulative incidence of a diagnosis of fibroids in women aged 25 to 45 is approximately 30 percent.
Uterine fibroids can cause abnormal uterine bleeding, dysmenorrhea, lower back pain and non-cyclic pelvic pain. They also can contribute to symptoms related to an enlarging pelvic mass (e.g., urinary frequency or constipation).
Uterine fibroids are also associated with an increased risk of complications of pregnancy, and with infertility, although it is unclear whether this association is causative. Symptoms associated with uterine fibroids can have a significant impact on quality of life, with scores on standard measures that are comparable to those for other major chronic diseases
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
- 30 Years 至 53 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Uninterested in fertility during the study.
- •Premenopausal status.
- •Active symptoms related to uterine fibroids.
- •Subjects will be obligated to use non hormonal contraceptives during the study.
排除标准
- •Abnormal liver and renal function
- •Participants with significant increase in uterine fibroids size during a short time.
- •Exclusionary health problems contraindicating mifepristone included adrenal disease; sickle cell anemia; severe liver, respiratory, or renal disease; and blood clotting defect.
- •Current use of steroids, anticoagulants, herbals, or botanicals with possible hormonal effects.
研究组 & 干预措施
antiprogestin
Daily use of 10 mg administrated per vagina
干预措施: mifepristone vaginal tablets (Drug)
结局指标
主要结局
Decrease of uterine fibroids volume by 25% and up.
时间窗: 1 year
次要结局
未报告次要终点