A PHASE III, RANDOMIZED, MULTI-CENTER, OPEN-LABEL, FOLLOW-ON STUDY FOR LONG T

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。 这是完成ARD-0403-004研究的第三阶段，多中心，开放标签，关于睾酮乳膏在睾酮缺乏男性中的长期安全性和有效性的后续研究。 完成第三阶段方案ARD-0403-004试验的所有受试者(最多150人)将被邀请参加这项扩展研究。大约有20个科目将从我们中心录取。这项研究的目的是证明ARD-0403，一种睾酮乳膏，对被诊断为睾酮缺乏症的男性的长期安全性、耐受性和有效性。 每个受试者都将在“第12周末”访问ARD-0403-004(IRB#12843-01)期间，接受这项研究的知情同意程序和纳入阶段。受试者将被充分告知所有相关的程序及其潜在的风险和好处；在自愿签署研究的知情同意书之前，将解决任何问题。知情同意讨论将持续到受试者和取得同意者双方都确信审判的描述令人满意，且受试者对他们参与的后果有合理的了解。潜在的受试者将有充分的机会阅读知情同意文件，并考虑他们是否想要参与研究。 在主要研究的第12周访问结束时收集的信息将作为后续研究的基线措施继续进行。

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, multi-centre, open-label, follow-on study for long-term safety and efficacy of testosterone cream, in testosterone deficient men completing study ARD-0403-004. All subjects completing the Phase III protocol ARD-0403-004 trial (Up to 150 men) will be invited to enter this extension study. About 20 of the subjects will be enrolled from our center. The objective of the study is to demonstrate the long term safety, tolerability and efficacy of treatment with ARD-0403, a testosterone cream, in men diagnosed to have testosterone deficiency. Each subject will undergo the informed consent process and inclusion phase for this study during their "End of Week 12" visit for protocol ARD-0403-004 (IRB#12843-01). Subjects will be fully informed of all associated procedures and their potential risks and benefits; and will have any questions addressed prior to voluntarily signing the informed consent for the study. The informed consent discussion will last until both the subject and the person obtaining consent feel confident that the trial has been satisfactorily described and the subject has a reasonable understanding of the consequences of their participation. Potential subjects will be given ample opportunity to read the informed consent document and consider whether or not they want to participate in the study. Information collected during the End of Week 12 visit of the main study will be carried over as baseline measures for the follow-on study.