A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of 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
- 71
- 试验地点
- 16
- 主要终点
- To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
研究概览
简要总结
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
详细描述
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.
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 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.
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.
研究组 & 干预措施
25 g Proellex
25 mg oral daily dose of Proellex
干预措施: Proellex (Drug)
50 mg Proellex
50 mg oral daily dose of Proellex
干预措施: Proellex (Drug)
Placebo
Placebo treatment
干预措施: placebo (Other)
结局指标
主要结局
To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)
时间窗: 4 months
次要结局
未报告次要终点