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.

这个子项目是众多研究子项目之一