A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 20
- 主要终点
- To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
研究概览
简要总结
Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
详细描述
Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least one uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- •Subject must have uterine fibroid-associated symptoms during the-screening visit
- •Subject has menstrual cycle lasting from 20 to 40 days
- •Other inclusion criteria may apply
排除标准
- •Post-menopausal women or women likely to become post-menopausal during the study
- •Subject with a significant organ abnormality or disease (based on the Investigator's judgment) that would in the opinion of the Investigator exclude the subject from participating
- •Subject with any medical condition that, in the opinion of the Investigator, is not compatible with study procedures or which would prevent the subject from starting or completing the study, or interfere with the subject participating in this study.
- •Subject who has had an acute illness within five days of study medication administration
- •Subject with endometrial thickness of ≥ 18 mm on screening ultrasound or historically
- •Subject with an abnormal screening endometrial biopsy including the presence of Endometrial Intraepithelial Neoplasia (EIN)
- •Subject with an abnormal DEXA scan with a diagnosis or indication of osteoporosis at screening
研究组 & 干预措施
25 mg
25 mg Proellex
干预措施: Proellex (Drug)
50 mg
50 mg Proellex
干预措施: Proellex (Drug)
结局指标
主要结局
To evaluate the safety of 25 and 50 mg Proellex administered once daily for two treatment cycles
时间窗: Four months each cycle
次要结局
- To evaluate the efficacy of two different doses of Proellex used for the treatment of symptomatic uterine fibroids(Two, 4 month cycles)