Treatment of Uterine Myoma With 2.5 or 5 mg Mifepristone Daily During 3 Months With 9 Months Post-treatment Follow-up. Randomized Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
研究概览
简要总结
Objectives: to evaluate the efficacy, safety and quality of life by using 2.5 and mifepristone 5 mg daily doses to treat uterine fibroids over 3 months with a 9 months follow-up period.
The hypothesis of the study is that the 2.5 mg dosage resulted in a lesser reduction in fibroid size but a similar improvement in quality of life when compared to the 5 mg dose.
详细描述
Women, in fertile age or in premenopausal status, presenting symptomatic uterine fibroids were randomly assigned to receive 5 mg or 10 of mifepristone.
The diminishing of prevalence of symptoms attributable to uterine fibroids is the most important goal to achieve under both treatments. The possible side effects of mifepristone are slight and women's adherence to treatment is remarkable. Also the reduction of the volumes of the uterus and fibroids contribute to enhance the wellbeing of subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Symptomatic uterine leiomyomata
- •Reproductive age or premenopausal
- •Accepting the use of non hormonal contraception
- •Conformity in keeping a monthly log of all episodes of vaginal bleeding during the treatment as well as all side effects of mifepristone
- •Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- •Agreeing to two endometrial biopsies: one before starting treatment and another in the following 10 days after treatment termination
排除标准
- •Pregnancy or desire to become pregnant
- •Breastfeeding
- •Hormonal contraception or any hormonal therapy received in the last three months
- •Signs or symptoms of pelvic inflammatory disease
- •Adnexal masses
- •Abnormal or unexplained vaginal bleeding
- •Suspected or diagnosed malignant neoplastic disease
- •Signs or symptoms of mental illness
- •Adrenal disease
- •Sickle cell anemia
- •Hepatic disease
- •Renal disease
- •Coagulopathy
- •Any other severe or important disease
- •Any contraindication to receiving antiprogestins
研究组 & 干预措施
Mifepristone 2.5 mg daily for three months
Experimental: 1
干预措施: Oral administration of mifepristone 2.5 mg daily for three months (Drug)
Mifepristone 5 mg daily for three months
Experimental: 2
干预措施: Oral administration of mifepristone 5 mg daily for three months (Drug)
结局指标
主要结局
Volume of the uterine leiomyomata with 2,5mg vs 5 mg daily of mifepristone after 3 months of treatment
时间窗: 3 months
Evaluate efficacy were the percentage changes in fibroid volumes before starting, 3 into treatment and 3, 6, and 9 months after its termination
次要结局
- Volume of the uterus with 2,5 mg vs 5 md daily of mifepristone after 3 months of treatment.(3 months)
研究者
Dr. Josep LLuis Carbonell i Esteve
Medical Director
Mediterranea Medica S. L.