Randomized Control Trial Of Mifepristone for Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Uterine Volume
研究概览
简要总结
The purpose of this trial is to determine if low-dose mifepristone benefits women with symptomatic fibroids.
详细描述
This trial is designed to assess the efficacy and tolerability of mifepristone 5 mg given daily for 6 months to pre-menopausal women with symptomatic fibroids. The primary study outcome will be disease-specific quality of life. Secondary outcome measures include global quality of life, pain, bleeding, potential adverse effects, tumor size, and endometrial effects. The researchers will also examine a the effect of mifepristone on uterine blood flow. Randomization of study subjects will be stratified in order to ensure that equal numbers of women with moderate and severe symptoms will be enrolled in the placebo and control groups.
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
- Triple (Participant, 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
- 是
入选标准
- •Gender: Female
- •Age: 18 - premenopausal
- •Have at least moderate symptoms of menorrhagia or pelvic pain/pressure
- •Have a total uterine volume greater than or equal to 160 cc by ultrasound measurement and at least one fibroid that is => 2.5cm in size
- •Have a score of equal to or greater than 39 on the Uterine Fibroid Symptom and Quality of Life scale
- •Declined standard treatment options for symptomatic fibroids
- •Agree to use a double-barrier method (condoms, diaphragms) or other effective non-hormonal methods of contraception (abstinence, sterilization) throughout participation in the study to prevent pregnancy and to report any exposure to pregnancy to the research staff immediately
- •Willing and able to give informed consent
- •Willing and able to comply with study requirements
排除标准
- •Current or planned pregnancy during the study period
- •Menopausal, as indicated by follicle stimulating hormone (FSH) level of the reference laboratory
- •Currently breast-feeding
- •Untreated abnormal pap smear
- •Presence of conditions other than fibroids contributing to pain and/or bleeding
- •Hemoglobin < 9.0 mg/dl
- •Presence of adnexal masses or tenderness indicating further evaluation or surgery
- •Grade III or IV hydronephrosis by ultrasound
- •Severe, active mental health disorder
- •Active substance abuse or dependence
- •Presence of any contraindication to mifepristone including:
- •Adrenal insufficiency by history
- •Sickle cell disease
- •Active liver disease (liver function tests greater than 1.5 times upper range of normal)
- •Severe, respiratory disease (P02 saturation< 92%)
- •Renal disease (serum creatinine > 1.5 mg/dl)
- •Blood clotting defect. (abnormal PT and PTT)
- •Thromboembolic disease (history of deep vein thrombosis or pulmonary embolus)
- •Current or recent (within the past 3 months) use of the following medications:
- •Oral or systemic corticosteroids
- •Hormones: estrogens, progestins, oral contraceptives
- •Danazol, anticoagulants
- •Herbal or botanical supplements with possible hormonal effects.
- •Use within the past six months of the gonadotropin releasing hormones (GnRH) analogs or Depo-Provera.
- •Current or planned use during the study of any of the following medications/or products:
- •ketoconazole,
- •itraconazole,
- •erythromycin,
- •grapefruit juice,
- •rifampin,
- •St John's Wort,
- •phenytoin,
- •phenobarbital, or
- •carbamazepine
研究组 & 干预措施
Mifepristone
Mifepristone 5 MG capsule taken once daily by mouth
干预措施: Mifepristone (Drug)
Inert capsule
Placebo (for Mifepristone) capsule of nearly identical color, size, and weight taken once daily by mouth
干预措施: Inert Capsule (Drug)
结局指标
主要结局
Uterine Volume
时间窗: 6 months
Uterine volume is measured in mLs
次要结局
未报告次要终点
研究者
Kevin Fiscella
Tenured Professor
University of Rochester