A Phase 2, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of Asoprisnil (J867) in Patients With Uterine Leiomyomata.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 129
- 主要终点
- Percent change from baseline in uterine volume and volume of the largest fibroid.
研究概览
简要总结
This study was designed to determine the safety and effectiveness of 3 asoprisnil doses compared to placebo, taken for 12 weeks by women with uterine fibroids.
详细描述
No medical therapy is currently available for the long-term treatment of uterine fibroids. The objective of this study is to determine the safety and efficacy of asoprisnil 5 mg, 10 mg and 25 mg, compared to placebo, taken daily for 12 weeks by women with one or more uterine fibroids, confirmed by ultrasound. Upon completion, subjects at participating sites will be allowed to enter an open-label extension study
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Women between 18 and 49 years of age
- •Diagnosis of either 1 or more uterine fibroids
- •History of regular menstrual cycles of 21 to 35 days in length.
排除标准
- •Any abnormal lab result the study-doctor considers significant
- •History of severe reaction to or current use of hormone therapy
- •History of osteoporosis or other bone disease
- •History of uterine artery embolization, cryomyolysis, or electrical myolysis
- •Subject currently breast feeding
- •Hemoglobin < 8 g/dL at baseline
研究组 & 干预措施
4
干预措施: Placebo (Drug)
1
干预措施: Asoprisnil (Drug)
2
干预措施: Asoprisnil (Drug)
3
干预措施: Asoprisnil (Drug)
结局指标
主要结局
Percent change from baseline in uterine volume and volume of the largest fibroid.
时间窗: Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6.
Duration of amenorrhea
时间窗: Day 1 to 1st post treatment menses
次要结局
- Change from baseline in uterine size in gestational weeks.(Treatment weeks 4, 8, 12 and Post-treatment months 3 and 6)
- Number of Subjects in each treatment group achieving> or = to 20% reduction in uterine volume.(Week 12 and final visit)
- Percentage of days with bleeding.(Day 1 through end of 1st post-treatment menses)
- Changes in hematologic and iron parameters.(Baseline to each visit)
- Uterine fibroid symptom improvement.(Baseline to each visit)
- Response to Global Efficacy Question regarding improvement in fibroid symptoms.(Week 12 and Final Visit)