NCT00683917终止2 期
A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 4
- 主要终点
- The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
研究概览
简要总结
PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
详细描述
The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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 subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive
- •Surgical interventions for uterine fibroids (e.g., hysterectomy, myomectomy, or uterine arterial embolization) must not be planned or anticipated during the study
- •Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding
- •Regular or steady menstrual cycle lasting from 24 to 36 days
- •Willing to comply with all study procedures including the endometrial biopsies and PK blood draws for all visits including follow-up visits
- •Subject must agree to use a medically acceptable and effective non-hormonal, double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug
排除标准
- •Documented endometriosis or active pelvic inflammatory disease
- •History of alcohol and/or drug abuse
- •Any history or diagnosis of gynecological cancer or cervical dysplasia
- •Use of an IUD
- •Use of prohibited concomitant medications:
- •Use of Depo-Provera must cease 10 months prior to first dose of study drug
- •Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of study drug and Lupton® Depot 8 months prior to the first visit
- •Known active infection with HIV; Hepatitis A, B or C; gonorrhea; or chlamydia
研究组 & 干预措施
Proellex 25 mg
Experimental
Proellex 25 mg
干预措施: Proellex 25 mg (Drug)
Proellex 50 mg
Experimental
Proellex 50 mg
干预措施: Proellex 50 mg (Drug)
Lupron
Active Comparator
Lupron Depot
干预措施: Lupron Depot (Drug)
结局指标
主要结局
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.
时间窗: 4 months
次要结局
未报告次要终点
研究者
研究点 (4)
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