NCT00830414已完成1 期
A Pivotal Study to Evaluate the Bioequivalence of 150 mg/1 mL Medroxyprogesterone Acetate Injection in Postmenopausal Women
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Bioequivalence based on Cmax and AUC
研究概览
简要总结
This study compared the rates and extents of medroxyprogesterone absorption from two medroxyprogesterone acetate injection formulations following single 150 mg intramuscular (IM) injections to healthy postmenopausal women.
详细描述
Criteria for Evaluation: FDA Bioequivalence Criteria
Statistical Methods: FDA bioequivalence statistical methods
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: medroxyprogesterone acetate (Drug)
2
Active Comparator
DEPO-PROVERA®
干预措施: medroxyprogesterone acetate (Drug)
结局指标
主要结局
Bioequivalence based on Cmax and AUC
时间窗: 120 days
次要结局
未报告次要终点
研究者
研究点 (1)
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