NCT00448955已完成3 期
A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 24
- 主要终点
- Pharmacokinetic
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 wellbeing. 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
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
Pharmacokinetic
次要结局
- Safety and tolerability
研究者
研究点 (24)
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