A Phase 3, 12-Month, Extension Study to Evaluate the Safety of Asoprisnil 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
- 523
- 主要终点
- The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
研究概览
简要总结
The objective of this study is to determine the long-term safety of asoprisnil in 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 long-term safety of asoprisnil 10 and 25 mg tablets administered daily for 12 months to women with abnormal uterine bleeding associated with uterine fibroids after an initial 12 months in M01-390 or M01-394. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts (if applicable), bone and lipid profiles, adverse events, and changes from baseline laboratory values and vital signs.
Some subjects receiving asoprisnil developed endometrial changes. As a result, dosing was prematurely discontinued for all subjects. To ensure safety, subjects will remain on study and will undergo scheduled study procedures. In most subjects, endometrial changes reversed after asoprisnil discontinuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Women who have completed 12 months of treatment in study M01-390 or study M01-394 and their Visit 12 procedures, respectively
- •Otherwise in good health
- •Premenopausal based on Estrogen and FSH levels
- •Agrees to use of double barrier method of contraception
- •Adequate endometrial biopsy with no significant histological disorder
排除标准
- •Any abnormal lab or procedure result(s) the study-doctor considers important
- •Significant gynecological disorder such as confirmed endometrial polyp
- •Hemoglobin < 8.0 g/dL
- •History of a blood-clotting disorder
- •Any prior surgical and/or invasive procedure(s) for uterine fibroids that resulted in either a cure or made the symptoms go away.
研究组 & 干预措施
1
干预措施: Asoprisnil (Drug)
2
干预措施: Asoprisnil (Drug)
结局指标
主要结局
The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.
时间窗: Month 12
次要结局
- The percent of subjects who demonstrate a clinically meaningful improvement in bleeding and do not require surgical/invasive intervention.(Month 6)
- Change from baseline in menstrual pictogram bleeding score.(Final Month)
- Change from baseline in the number of days with bleeding.(Final Month)
- Change from baseline in hemoglobin concentration.(Final Visit)
- Percent change from baseline in the 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 the Uterine Fibroid Symptom-Quality of Life total score.(Final Visit)
- Cumulative percent of subjects who achieve amenorrhea.(Each Month)