A PHASE II RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE STEADY STATE PHARMACOK

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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 research study is to see how much testosterone (male hormone) remains in the blood at different times after treatment with two different doses of testosterone lotion (Testosterone Metered Dose (MD) -Lotion¿). These experimental doses of testosterone MD lotion have not been approved by the U.S. Food and Drug Administration for use in patients. Each of the two doses of testosterone lotion will be in a bottle fitted with a pump and the lotion is applied daily to the armpits. Previous studies have shown that this testosterone lotion applied to the armpits increase and maintain (keep constant) the levels of testosterone in the body. You will receive the two doses of testosterone lotion (30 or 60 mg) over a period of 7 days for each dose in this study. The study drug (Testosterone Metered Dose (MD) -Lotion¿) is made and will be provided by Acrux Pharma Pty. Ltd., Australia, the company that is sponsoring this study.