NCT00220298已完成3 期
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 96
- 主要终点
- Efficacy and Safety of long term treatment with TU under real-life conditions
研究概览
简要总结
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency
排除标准
- •Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Testosterone undecanoate (TU) - NebidoTM (Drug)
结局指标
主要结局
Efficacy and Safety of long term treatment with TU under real-life conditions
时间窗: Every 3 months during treatment and after final injection
次要结局
- Assessment of treatment satisfaction by patient(6,10, and 14 injections)
研究者
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