The Effectiveness and Safety of Ulipristal Acetate in Women With Symptomatic Uterine Fibroid
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Amenorrhea
研究概览
简要总结
This study evaluates the effectiveness and safety of ulipristal acetae (UPA) in women with symptomatic uterine fibroids. Those who fulfilled inclusion/exclusion criteria will be treated UPA at daily dose of 5mg.
详细描述
There is increasing evidence approving role of medical therapy in treatment of symptomatic uterine fibroid, in the context of women's desire to preserve fertility or not to undergo operation.
Among these hormonal therapies, ulipristal acetate (UPA) is an orally administered selective progesterone receptor modulator commonly prescribed for treatment of uterine fibroid. This agent acts on causing apoptosis of the muscle cells inside the tumor and reducing the tumor matrix in case of uterine fibroid.
UPA at daily dose of 5 mg has been shown to decrease menstrual blood loss and reduce tumor size after 13 consecutive weeks of treatment.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-48
- •Regular cycle of 22-35 days interval and FSH <=20 mUI/mL.
- •>=1 uterine fibroid of 3<= d < 10cm (regardless of location), diagnosed by transvaginal ultrasound.
- •Heavy menstrual bleeding (blood loss >80ml/cycle).
- •Uterine size < 16 weeks of GA on clinical examination.
- •Agree to participate in the study.
排除标准
- •Previous or current treatment of uterus, cervix, ovarian or breast cancer.
- •Previous endometrial ablation or uterine artery embolization.
- •Abnormal PAP's smear result within 12 months prior to recruitment.
- •Endometrial hyperplasia within 6 months prior to recruitment.
- •Uterine polyp >2cm.
- •Ovarian cysts 4cm diagnosed by transvaginal ultrasound.
- •Severe anemia (Hb 6 g/dl) or indication for blood transfusion.
- •Coagulation disorder indicated for treatment.
- •Increased liver enzyme level of twofold or more than normal upper limit.
- •Previous use of SPRM.
- •Treatment of systemic progestin or intrauterine device or hormonal contraception within 2 months, or use of GnRH analogue within 5 months prior to recruitment.
- •Current use of acetylsalicylic acid, mefenamic acid, anticoagulation agents, antifibrinolysis agents, or systemic corticoid
研究组 & 干预措施
Ullipristal Acetate
Women with symptomatic uterine fibroids will be treated with 5 mg UPA / day in 3 months
干预措施: Ulipristal Acetate 5 mg (Drug)
结局指标
主要结局
Amenorrhea
时间窗: from first dose to the end of 3 consecutive months of treatment course
Percentage of subjects achieve amenorrhea at the end of treatment. Amenorrhea is defined of 35 consecutive non-bleeding days, in which spotting is accepted.
次要结局
- Abnormal endometrial features and thickness(from first dose to the end of 3 consecutive months of treatment course)
- adverse events(from first dose to the end of 3 consecutive months of treatment course, and the end of 3 months follow-up without treatment)
- Uterine fibroid symptom and health - related quality of life score change(from first dose to the end of 3 consecutive months of treatment course)
- abnormal liver function test findings(from first dose to the end of 3 consecutive months of treatment course)
- uterine fibroid size change(from first dose to the end of 3 consecutive months of treatment course)
- pelvic pain control(from first dose to the end of 3 consecutive months of treatment course)
- time from treatment to amenorrhea(from first dose to the end of 3 consecutive months of treatment course)