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

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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.