A Phase I Trial to Determine the Impact of Application of Antiperspirant and Deodorant as Well as Washing the Application Site, on the Pharmacokinetics of Testosterone Following Single Dose Applications of 2% Testosterone MD-Lotion® (Cutaneous Solution)

Acrux DDS Pty Ltd1 个研究点分布在 1 个国家目标入组 36 人开始时间: 2009年1月最近更新: 2009年10月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Acrux DDS Pty Ltd
入组人数: 36
试验地点: 1
主要终点: To evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution). Also to evaluate the impact of washing.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

排除标准

•Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.