NCT00562731终止3 期
A Phase III, Open-Label Follow-on Study for Long-Term Safety and Efficacy of Testosterone Cream, in Testosterone Deficinet Men Completing Study ARD-0403-004
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 24
- 主要终点
- Efficacy
研究概览
简要总结
Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Testosterone deficiency
- •Completed study ARD-0403-004
排除标准
- •Previous treatment with testosterone replacement therapy within 4 weeks
- •Moderate-severe benign prostatic hypertrophy or prostatic cancer
- •Haematocrit >50%
结局指标
主要结局
Efficacy
时间窗: Study Duration
次要结局
- Safety and Tolerability(Study Duration)
研究者
研究点 (24)
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