A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 175
- 试验地点
- 25
- 主要终点
- To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
研究概览
简要总结
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
详细描述
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Speak, read and understand English or Spanish;
- •Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
- •One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
- •Menstrual cycle lasting from 24 to 36 days;
- •History of excessive menstrual bleeding;
- •Negative urine pregnancy test at screening.
- •Additional inclusion criteria may apply.
排除标准
- •Six months or more (immediately prior to Screening Visit) without a menstrual period;
- •Prior hysterectomy;
- •Prior bilateral oophorectomy;
- •Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
- •Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
- •Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
- •Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
- •Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
- •Additional exclusion criteria may apply.
研究组 & 干预措施
25 mg Proellex
Proellex 25 mg once daily
干预措施: Proellex 25 mg (Drug)
Proellex 50 mg
Proellex 50 mg once daily
干预措施: Proellex 50 mg (Drug)
结局指标
主要结局
To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
时间窗: 12 months
次要结局
未报告次要终点