A Phase 2, Long-Term, Open-Label, Safety Extension Study 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
- 38
- 主要终点
- Percent change from baseline in uterine volume and volume of the largest fibroid from pre-treatment in study M99-144
研究概览
简要总结
This study was designed to determine the long-term safety of asoprisnil 10 mg in women with one or more uterine fibroids after an initial 12 weeks in study M99-144.
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 long-term safety of asoprisnil 10 mg daily for 6 months, after an initial 12 weeks in study M99-144, in women with one or more uterine fibroids, confirmed by ultrasound in study M99-144. The safety endpoints for this study will be based on ultrasound and endometrial biopsy results, adverse events, and any changes from baseline laboratory values and vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completed dosing and Day 84 procedures at sites in study M99-144
- •No interruption of dosing
- •Otherwise continued good health
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 alcohol or drug abuse
研究组 & 干预措施
1
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 from pre-treatment in study M99-144
时间窗: Treatment months 3 and 6 and Post-treatment months 3 and 6
Percentage of subjects that achieved amenorrhea.
时间窗: Treatment months 1-6
次要结局
- Improvement in hematologic parameters.(Treatment months 2,4,and 6)
- Change from baseline in uterine size in gestational weeks.(Months 3 and 6)
- Mean change from baseline for endocrine determinations.(Months 2,4 and 6)
- Improvement in Uterine fibroid symptoms(menorrhagia, metrorrhagia, pelvic pressure, bloating, urinary disorders, pelvic pain, dysmenorrhea, dyspareunia) using a 4 point scale(Treatment Months 1-6)
- Duration of amenorrhea.(Start of previous study to first post-treatment menses.)
- Response to global efficacy question regarding improvement of fibroid symptoms.(Month 6)