CLINICAL TRIAL: TRIAL TO EVALUATE THE EFFECTIVENESS AND SAFETY OF DIFF DOSES OF

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项研究的目的是确定一种新的男性荷尔蒙睾丸素MD-洗液(皮肤液)是如何在人体内代谢的，以及它是否安全和耐受性良好。这将通过给性腺功能低下的男性(男性激素缺乏的男性)皮肤(皮肤溶液)应用不同剂量的睾酮MD-乳液来实现，并测量在设定的时间点(药代动力学，PK)有多少药物残留在血液中。睾丸激素MD-乳液(皮肤溶液)以乳液的形式出现在腋下(腋窝)的皮肤上。这项研究将需要长达24周的时间来完成，所有受试者将在研究的120天治疗期内接受积极的研究药物治疗。 目前可用的睾酮替代疗法包括口服制剂(口服)、注射、凝胶和凝胶贴片(用于皮肤)。除了现有的睾酮凝胶配方外，睾酮MD-Lotion可能提供了另一种将睾酮应用于皮肤的方法。睾丸素乳液涂在腋下，对皮肤的刺激最小，可能会减少将药物转移到他人身上的机会。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The purpose of this study is to determine how a new formulation of male hormone Testosterone MD-Lotion¿ (cutaneous solution) is metabolized by human body and if it is safe and well tolerated. This will be done by giving different doses of Testosterone MD-Lotion¿ applied to the skin (cutaneous solution) to hypogonadal men (men deficient in male hormone testosterone) and measuring how much of the medication remains in the blood at set time points (pharmacokinetics, PK). Testosterone MD-Lotion¿ (cutaneous solution) comes in a form of a lotion to be applied to the skin of axillae (armpits). The study will take up to 24 weeks to complete and all subjects will receive the active study medication for 120 days of the Treatment Period of the study. Testosterone replacement therapies currently available include oral formulations (taken by mouth), injections, gel and gel patches (to be applied to skin). Testosterone MD-Lotion¿ may provide another way to apply testosterone to the skin in addition to the available gel formulations of testosterone. The testosterone lotion is applied to the axillae, has minimal skin irritation, and may decrease chances of transferring the medication to others.