NCT00152256已完成3 期
A Phase 3,6-Month, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Two Doses of Asoprisnil Versus Placebo in Subjects With Uterine Leiomyomata
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 239
- 主要终点
- Cumulative percent of subjects achieving amenorrhea.
研究概览
简要总结
The objective of this study is to determine the safety and efficacy effects of two doses of asoprisnil (10 mg and 25 mg) compared with placebo when administered daily for 6 months to premenopausal subjects with symptomatic uterine leiomyomata.
详细描述
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids. Asoprisnil (10 mg and 25mg) is being evaluated in a Phase 3 program to establish long term safety and effectiveness and therefore provide women with a medical alternative to surgery.
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 53 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women
- •History of regular menstrual cycles (21-42 days)
- •Diagnosis of uterine fibroid(s)
- •Abnormal vaginal bleeding associated with uterine fibroids
- •Otherwise in good health
- •Subject must have at least one fibroid with a diameter ≥ 2 cm or multiple small fibroids with a uterine volume of ≥ 200 cm3
排除标准
- •Less than 3 months postpartum and post-lactation
- •Previous myomectomy within 1 year
- •Any abnormal lab or procedure result the study-doctor considers important
- •Severe reaction(s) to or are currently using any hormone therapy
- •History of osteoporosis or other bone disease
研究组 & 干预措施
1
Experimental
干预措施: Asoprisnil (Drug)
2
Experimental
干预措施: Asoprisnil (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Cumulative percent of subjects achieving amenorrhea.
时间窗: Month 3
次要结局
- Change from baseline in total symptom severity score and the Uterine Fibroid Symptom-Quality of Life total score.(Final Visit)
- Change from baseline in menorrhagia, metrorrhagia, bloating, pelvic pressure, dysmenorrhea, pelvic pain and urinary symptoms.(Final Visit)
- Change from baseline in the Work Limitation Questionnaire Index.(Final Visit)
- Change from baseline in the two dimensions of the SF-36 (Physical Component Summary and Mental Component Summary).(Final Visit)
- Change from baseline in the monthly bleeding score.(Final Visit)
- Change from baseline in the hemoglobin concentration.(Final Visit)
- Change from baseline in volume of the largest fibroid.(Final Visit)
- Percentage of subjects who discontinue with the intent to have surgery for fibroids during treatment.(During treatment period)
- Percentage of subjects who respond positively to the global efficacy question.(Final Visit)
研究者
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