A PHASE III OPEN-LABEL STUDY OF THE EFFICACY AND SAFETY OF ARD-0403

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这是一项第三阶段的开放标记、剂量滴定、多中心研究。滴定被定义为逐渐调整药物剂量直到达到预期效果的过程。 预计将有多达150名睾丸激素缺乏的男性参加这项研究。他们每人每天将收到28份2.25G ARD-0403的申请。治疗28天后，如果睾酮水平不在参考的300-700 ng/dl范围内，ARD-0403的剂量将被滴定，如果血清睾酮水平低于300 ng/dl，剂量将增加2.25g至4.5g，如果水平高于700 ng/dl，剂量将减少到1.5g。在患者进入12周的维持期之前，可能会进行进一步的剂量滴定。 在参与这项研究之前，潜在的受试者将经历一个“纳入阶段”，以确定他们是否有资格参加这项研究。这一阶段将包括知情同意程序、取消目前的雄激素治疗(如果适用)、体检(包括直肠指检以检查前列腺大小)、心电图(CG)、安全实验室评估(包括PSA、血液学和血清激素水平)。受试者在参加这项研究之前，至少需要有两次血清总睾丸素水平的记录。 研究药物的安全性将通过评估收集的不良事件、严重不良事件(SAE)、心电图、生命体征、应用部位反应和临床实验室参数(生化和血液学)的安全数据进行评估。

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 is a phase III, open-label, dose-titration, multi-center study. Titration is defined as the process of gradually adjusting the dose of a medication until the desired effect is achieved. Up to 150 testosterone deficient men are expected to enter this study. Each of them will receive 28 daily applications of 2.25g ARD-0403. After 28 days of treatment, if testosterone levels are not within the reference 300- 700 ng/dL), the dose of ARD-0403 will be titrated, if serum testosterone levels are below 300 ng/dl, the dose will be increased by 2.25g to 4.5g and if the level is above 700 ng/dl, the dose will be decreased to 1.5 g. Further dose titrations may be made prior to patients entering a 12 week maintenance phase. Prior to participation in the study, potential subjects will undergo an "inclusion phase" to determine whether they are eligible for the study. This phase will include the informed consent process, washout of current androgen treatment (if applicable), physical examination (including a digital rectal exam to check prostate size), an electrocardiogram (ECG), safety laboratory assessments (consisting of PSA, hematology, and serum hormone levels). Subjects need to have documented serum total testosterone levels <250ng/dL on at least two occasions prior to enrolling into the study. Safety of the study drug will be assessed by evaluating the collected safety data of adverse events, serious adverse events (SAEs), ECG, vital signs, application site reactions and clinical laboratory parameters (biochemistry and hematology).