Comparison of the Safety and Efficacy of Intravenous Iron vs Oral Iron in the Treatment of Anemia Secondary to Heavy Uterine Bleeding
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
研究概览
简要总结
This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding
详细描述
This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.
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
- None
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
- •Female subjects >/= 18 years of age
- •History of Heavy uterine bleeding
- •Hgb </= 11
- •Practicing acceptable birth control
- •Demonstrate ability to understand and comply with protocol
排除标准
- •Known Hypersensitivity to oral or IV iron
- •Anemia other than iron deficiency anemia
- •Iron storage disorders
- •Initiation of treatment that may effect degree of heavy uterine bleeding
- •Anticipated need for surgery
- •Severe psychiatric disorder
- •Active infection
- •Positive Pregnancy test
- •Known Hep B or C or Active Hepatitis
- •Received investigational Drug within 30 days
- •Alcohol or drug abuse
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Ferrous Sulfate tablets
325 mg tablets TID on Days 0 through Day 42
干预措施: Ferrous Sulfate tablets (Drug)
结局指标
主要结局
Number of Subjects Achieving 'Clinical Success'. Clinical Success is Defined as an Increase in Hemoglobin of ≥ 2.0 g/dL
时间窗: Any time between baseline and the end of study or time to intervention
次要结局
未报告次要终点