An Open-Label Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure to Testosterone Gel 1.62% Applied to the Upper Arms and Shoulders and Use of a T-shirt Barrier
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Average Plasma Concentration observed (Cav)
研究概览
简要总结
Single-center, single dose, open-label study in healthy male and female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
详细描述
Single-center, single dose, open-label study in 12 healthy male and 12 healthy female volunteers to further characterize the transfer potential of Testosterone Gel 1.62% formulation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
干预措施: Testosterone Gel 1.62% (Drug)
结局指标
主要结局
Average Plasma Concentration observed (Cav)
时间窗: Up to 5 days
Average Plasma Concentration observed (Cav) of total testosterone
Maximum Plasma Concentration observed (Cmax)
时间窗: Up to 5 days
Maximum plasma concentration observed (Cmax) of total testosterone
Area Under the Plasma Concentration-time Curve (AUC)
时间窗: Up to 5 days
Area under the plasma concentration-time curve (AUC) of total testosterone
次要结局
未报告次要终点