A Randomized, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate in Women With Anemia Associated With Uterine Leiomyomas
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 46
- 主要终点
- Change from baseline in hemoglobin levels (g/dL)
研究概览
简要总结
The purpose of this study is to determine whether ulipristal acetate is effective in the treatment of females with anemia associated with uterine leiomyomas. The safety of this product will also be evaluated.
详细描述
This is a randomized, placebo controlled, multicenter study with parallel groups in order to evaluate the efficacy and safety of ulipristal acetate in female subjects with anemia associated with uterine leiomyomas. The objective of this study is to determine if daily ulipristal acetate with iron is more effective than iron alone.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Is a pre-menopausal female, 18 - 50 years;
- •Has documented leiomyoma(s);
- •Has leiomyoma-related anemia;
- •Has an endometrial biopsy within the screening period prior to the first dose of the test article which shows no endometrial hyperplasia;
- •Is willing and able to provide written informed consent and authorization to disclose protected health information.
排除标准
- •Has a history of uterine surgery that would interfere with the study;
- •Has a condition requiring immediate or intermittent blood transfusions;
- •Has a known coagulation disorder;
- •Has a history of uterine, cervix, ovarian, or breast cancer;
- •Has used a selective progesterone receptor modulator or a gonadotrophin releasing hormone agonist in previous 6 months;
- •Has received blood transfusion within 8 weeks before the screening visit;
- •Has abnormal liver functions;
- •Is pregnant.
研究组 & 干预措施
Placebo
Placebo with iron
干预措施: Iron (Drug)
Ulipristal with iron
干预措施: Iron (Drug)
Ulipristal with iron
干预措施: Ulipristal Acetate (Drug)
结局指标
主要结局
Change from baseline in hemoglobin levels (g/dL)
时间窗: Day 1 of the first on-treatment menstrual cycle to the start, or scheduled start of menstrual cycle 3.
Change from baseline in hemoglobin levels (g/dL)
次要结局
未报告次要终点