Mifepristone 5 mg Versus 10 mg During 6 Months for the Treatment of Uterine Leiomyomata. A Randomized, Double Blinded Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
研究概览
简要总结
The objectives of this study are to estimate the efficacy and safety of the daily administration for 6 months of 5 mg versus 10 mg. A 6 month follow-up of subjects is carried out to estimate how the effects of mifepristone are kept in time.
The hypothesis of this study is that both mifepristone doses reduce the volume of the myoma up to 50% in six months treatment.
详细描述
Women, in fertile age or premenopausal status, presenting symptomatic myomaswere randomly assigned to receive 5 or 10 mg of mifepristone for six months.
The decreasing in the prevalence of symptoms attributable to myomas is an important goal to achieve under both treatments. Another goal is to maintain for more than 6 months the benefits of the treatment with mifepristone.
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
- Double (Participant, Investigator)
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 fibroids
- •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 the side effects of mifepristone
- •Agreeing to have ultrasound examinations in every follow-up or evaluation visit
- •Agreeing in 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
Group 1
Oral administration of mifepristone 5 mg daily for six months.
干预措施: Mifepristone (Drug)
Group 2
Oral administration of mifepristone 10 mg daily for six months.
干预措施: Mifepristone (Drug)
结局指标
主要结局
Volume of the uterine leiomyomata with 5 versus 10 mg of mifepristone daily after six months of treatment
时间窗: 6 months
次要结局
- Prevalence of symptoms after 6 months treatment with 5 or 10 mg of mifepristone.(6 months)
研究者
Dr. Josep Lluis Carbonell i Esteve
Medical Director
Mediterranea Medica S. L.