A PHASE II, RANDOMISED, FOUR-WAY CROSSOVER STUDY TO COMPARE THE STEADY STATE

点击翻译按钮获取中文摘要

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. This study is a supplementary study to Protocol 12697 which we have completed this year. Protocol 12697 recruited 41 subjects in the United States. Though both the 30mg and 60 mg Testosterone lotion provided average serum testosterone levels in over 70 % of the subjects, there were a substantial number of subjects whose serum testosterone levels were below the normal range at some time ruing a 24 hours period. The sponsor in discussions with the PI of this project, decided to do another limited pharmacokinetics study with a new formulation of a 2% Testosterone lotion. This study will involve the administration of 4 doses of testosterone lotion for 7days for each dose level to men with androgen deficiency (male hypogonadism). The Primary Objective is to determine and compare the steady state pharmacokinetics (what happens to the blood levels) of four doses of testosterone lotion: * Treatment A: 3mL (30mg) of 1% Testosterone MD-Lotion(r) applied daily for 7 days to both axilla (1.5mL to each axilla). * Treatment B: 1.5mL (30mg) of 2% Testosterone MD-Lotion(r) applied daily for 7 days to one axilla.* Treatment C: 3mL (60mg) of 2% Testosterone MD-Lotion(r) applied daily for 7 days to both axilla (1.5mL to each axilla). * Treatment D: 4.5mL (90mg) of 2% Testosterone MD-Lotion(r) applied daily for 7 days by 3 doses to the axilla (2 x 1.5mL to one axilla and 1x1.5mL to the other axilla). The Secondary Objective is to assess whether Testosterone MD-Lotion¿ is safe and well tolerated.