A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 56
- 试验地点
- 29
- 主要终点
- Change in Hemoglobin vs Placebo
研究概览
简要总结
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
详细描述
Eligible female subjects will be randomly assigned to one of the three treatment groups. Subjects will receive 325 mg (65 mg elemental iron) iron supplements to be taken twice daily during study drug treatment. The study duration is approximately six months, which is comprised of a 4 - 6 week screening period, a three-month drug treatment period, and a one-month follow-up period.
Study was terminated by clinical hold.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- •Anemic, defined as hemoglobin levels less than or equal to 10.5 g/dL and uterine fibroid-associated symptoms indicated by a history of excessive menstrual bleeding;
- •Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy) planned or anticipated after the study;
- •Willing to comply with all study procedures, including the endometrial biopsies and blood draws for all visits, including Follow-up Visits
排除标准
- •Post-menopausal women or women likely to become post-menopausal during the study, defined as one or more of the following:
- •Six months or more (immediately prior to Screening Visit) without a menstrual period, or
- •Prior hysterectomy, or
- •Prior bilateral oophorectomy (unilateral oophorectomy is not exclusionary if regular menstruation is occurring);
- •Females who have undergone a uterine arterial embolization, or endometrial ablation therapy (previous myomectomy is acceptable) for any cause;
- •Documented endometriosis or active pelvic inflammatory disease (PID);
- •Having a diagnosis, or suspected diagnosis, of carcinoma of the breast or reproductive organs;
- •Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
- •Use of prohibited concomitant medications:
- •Depo-Provera use must cease ten months prior to first dose of study drug, or
- •GnRH agonists use (e.g. Lupron Depot) must cease six months prior to first dose of study drug, or
- •Oral contraceptive or other hormonal treatments use must cease for 30 days prior to the start of the study
研究组 & 干预措施
A 25 mg
Proellex 25 mg, 1 - 25 mg capsule and 1 placebo capsule daily for 3 months
干预措施: Proellex 25 mg (Drug)
B 50 mg
Proellex 50 mg, 2 - 25 mg capsules daily for 3 months
干预措施: Proellex 50 mg (Drug)
C Placebo
Placebo, 2 capsules daily for 3 months
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Hemoglobin vs Placebo
时间窗: 3 months
Comparison between 50 mg Proellex and placebo of change in hemoglobin at month 3
次要结局
未报告次要终点