A Phase III, 18-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
- 166
- 主要终点
- Long Term Safety
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 symptomatic uterine fibroids who completed the 6 month Study C02-037.
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 administered daily for 18 months to subjects with symptomatic uterine leiomyomata who completed the 6 month Study C02-037. The safety endpoints for this study will be based on assessments of the endometrium, ovarian cysts, lipid profiles, adverse events and clinical laboratory evaluations.
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 that have completed 6 months of treatment in study C02-037 with no more than a 7-day interruption in their treatment
- •Otherwise good health
- •Premenopausal based on Estrogen and Follicle Stimulating Hormone levels
- •Agrees to 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
- •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
- •Significant gynecological disorder, such as endometrial polyp
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
Long Term Safety
时间窗: Throughout 18 month treatment period
次要结局
- Cumulative and incremental amenorrhea rates.(Each month 1-18)
- Change from baseline in total symptom severity score and the Uterine Fibroid Symptoms-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 Uterine Fibroid Impact Questionnaire.(Months 6, 12, 18)
- Change from baseline in the Work Limitation Questionnaire Index.(Final Visit)
- Change from baseline in the two dimensions of the SF-36.(Final Visit)
- Change from baseline in the monthly bleeding score.(Final Month)
- Change from baseline in the hemoglobin concentration.(Final Visit)
- Percent 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 Period)
- Percentage of subjects who responded positively to the Global Efficacy Questions.(Months 6, 12, 18)