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

临床试验：评估不同剂量的有效性和安全性的试验

• 批准号: 8174509
• 负责人: CHRISTINA C. WANG
• 金额: $ 6.91万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-12-01 至 2010-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8174509
• 关键词: Axilla; Blood; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cutaneous; Dose; Drug Formulations; Drug Kinetics; Effectiveness; Funding; Gel; Grant; Hormones; Human body; Injection of therapeutic agent; Institution; Lotion; Measures; Oral; Oral cavity; Pharmaceutical Preparations; Research; Research Personnel; Resources; Safety; Skin; Solutions; Source; Testosterone; Time; United States National Institutes of Health; male; men; skin irritation; testosterone replacement therapy; treatment duration

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.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 本研究的目的是确定一种新配方的男性激素TequilMD-Lotion <$（皮肤溶液）是如何被人体代谢的，以及它是否安全和耐受性良好。这将通过向性腺功能减退的男性（缺乏雄性激素睾酮的男性）给予不同剂量的Tezoline MD-Lotion <$应用于皮肤（皮肤溶液）并测量在设定时间点（药代动力学，PK）血液中残留的药物量来完成。Teatrium MD-乳液<$（皮肤溶液）以乳液的形式应用于腋窝（腋窝）的皮肤。 研究将持续24周完成，所有受试者将在研究治疗期内接受120天的活性研究药物治疗。 目前可用的替吉奥替代疗法包括口服制剂（口服）、注射剂、凝胶和凝胶贴剂（用于皮肤）。除了可用的睾酮凝胶制剂外，Teastrophic MD-Lotion <$可能提供另一种将睾酮应用于皮肤的方法。睾酮乳液适用于腋窝，具有最小的皮肤刺激，并可能减少将药物转移到他人的机会。