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

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， 因此可以在其他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。 本研究是我们今年完成的方案12697的补充研究。方案12697在美国招募了41名受试者。虽然30 mg和60 mg的替吉奥洗剂在超过70%的受试者中提供了平均血清睾酮水平，但在24小时内的某个时间段内，有相当数量的受试者的血清睾酮水平低于正常范围。申办方与该项目的PI讨论后，决定使用2%替吉奥洗剂的新制剂进行另一项有限的药代动力学研究。 本研究将涉及对雄激素缺乏（男性性腺功能减退）男性给予4剂睾酮洗剂，每个剂量水平持续7天。 主要目的是确定和比较稳态药代动力学（发生了什么血液水平）的四个剂量的睾酮洗剂： * 治疗A：3 mL（30 mg）1%替吉奥MD-Lotion（r），每日一次，持续7天，涂抹于双侧腋窝（每个腋窝1.5 mL）。 * 治疗B：1.5 mL（30 mg）的2%替吉奥MD-洗剂（r），每天一次，持续7天。* 治疗C：3 mL（60 mg）2%替吉奥MD-Lotion（r），每日一次，持续7天，涂抹于双侧腋窝（每个腋窝1.5 mL）。 * 治疗D：4.5 mL（90 mg）2%替尼泊金MD洗剂（r），每日一次，连续7天，分3次涂抹于腋窝（一个腋窝2 x 1.5 mL，另一个腋窝1 x 1.5 mL）。 次要目的是评估TeasthenMD-Lotion？是否安全且耐受性良好。

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.