A Phase III, 12-Month, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of J867 Versus Placebo in Subjects With Uterine Leiomyomata.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 432
- 主要终点
- The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
研究概览
简要总结
The objective of this study is to determine the safety and effectiveness of asoprisnil in symptomatic women with abnormal uterine bleeding associated with uterine fibroids.
详细描述
No medical therapy is currently available for the long-term treatment of abnormal uterine bleeding associated with uterine fibroids in women and many women must resort to surgery for relief. The objective of this study is to determine the safety and efficacy of asoprisnil 10 mg and 25 mg tablets, compared to placebo, administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids, by assessing whether asoprisnil administration prevents surgical and/or invasive intervention in the study population. Women, who meet the predefined uterine bleeding criteria for surgical and/or invasive intervention (hysterectomy, myomectomy, uterine artery embolization) who are willing to undergo surgical and/or invasive intervention if the study medication fails, will be enrolled in this 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 —（Adult, Older 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
- •Agrees to undergo surgery (hysterectomy) or any other invasive procedure if the study medication fails
- •Negative pregnancy test
- •Agrees to Double-barrier method of contraception
- •Pap smear with no evidence of malignancy or pre-malignant changes
- •Endometrial biopsy with no significant histological disorder
排除标准
- •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
- •Previous myomectomy with 1 year and/or previous uterine artery embolization within 6 months
- •History of Polycystic Ovary Syndrome or prolactinoma
- •MRI shows significant gynecologic disorder
- •Uterine size > 25 weeks gestation
- •Hemoglobin < 8 g/dL at Day -1
研究组 & 干预措施
1
干预措施: Asoprisnil (Drug)
2
干预措施: Asoprisnil (Drug)
3
干预措施: Placebo (Drug)
结局指标
主要结局
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.
时间窗: Month 12 or Final Visit
次要结局
- Percent of subjects with clinically meaningful improvement in bleeding and who do not require surgical/invasive intervention.(Month 6)
- Change from baseline in menstrual pictogram score.(Final Month)
- Change from baseline in number of days with bleeding.(Final Month)
- Change from baseline in hemoglobin concentration.(Final Visit)
- Percent change from baseline in volume of the largest fibroid.(Final Visit)
- Change from baseline in bloating, pelvic pressure, dysmenorrhea and urinary symptoms.(Final Visit)
- Change from baseline in total symptom severity score and UFS-QOL total score.(Final Visit)
- Cumulative percent of subjects who achieve amenorrhea.(Month 3)