NCT01104246已完成1 期
An Open Label, Dose-Titration Investigation of the Pharmacokinetics, Metabolism and Safety of Testosterone Transdermal Systems in Hypogonadal Men
Watson Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
研究概览
简要总结
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
详细描述
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total testosterone and metabolites will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Males in good general health, 18 years of age or older.
- •Have a previously documented testosterone deficiency.
- •Willing and able to comply with the requirements of the protocol.
排除标准
- •Have a history of intolerance to Androderm or other testosterone products.
- •Prostate specific antigen (PSA) level ≥ 4.0 ng/mL
- •Prostate cancer or severe benign prostatic hypertrophy (BPH)
- •Have significant abnormalities in the physical examination at screening.
- •Have current dermatological disease, skin damage or blemishes.
- •Have participated in an investigational drug study within 30 days prior to screening.
研究组 & 干预措施
Testosterone Transdermal Systems
Experimental
Testosterone
干预措施: Testerone Transdermal System (Drug)
结局指标
主要结局
Time-average (Cavg) Steady State Testosterone Concentration Over 24 Hours
时间窗: Day 28/29
A 24-hour pharmacokinetic sampling was performed on Day 28/29 after the start of dosing.
次要结局
未报告次要终点
研究者
研究点 (1)
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