Three-Year Trial on a New Testosterone Gel: Clinical Efficacy, Tolerability and Compliance
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 100
- 试验地点
- 30
- 主要终点
- testosterone levels
研究概览
简要总结
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff.
详细描述
The objective of the study is to examine the efficacy and tolerability of a three-year-Testosterone replacement therapy in hypogonadal patients as well as the patient's compliance. The replacement therapy will be performed with a new Testosterone Gel examined in previous trials as Testosteron Gel Wolff (TGW).
A minimum of 100 patients will be recruited and evenly distributed to two treatment arms. 1st arm: dermal (non-scrotal) application of TGW. 2nd arm: scrotal application of TGW.
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
- Male
- 接受健康志愿者
- 否
入选标准
- •hypergonadotropic hypogonadism
- •hypogonadotropic hypogonadism
- •late-onset hypogonadism
- •combined with an initial Testosterone serum level of < 11 nmol/l
排除标准
- •known or suspected carcinoma of the prostate
- •clinically relevant abnormalities in clinical chemistry or haematology
- •any severe medical conditions at the opinion of the investigator
结局指标
主要结局
testosterone levels
次要结局
- sexual function and mood disorder (questionnaire)
- hormones
- compliance (drug accountability)