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

III 期、随机、多中心、开放标签、长期跟踪研究

• 批准号: 7952264
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 0.56万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952264
• 关键词: Address; Benefits and Risks; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Consent; Consent Forms; Cream; Diagnosis; Enrollment; Funding; Grant; Informed Consent; Institution; Longitudinal Studies; Measures; Persons; Phase; Phase III Clinical Trials; Procedures; Process; Protocols documentation; Randomized; Reading; Research; Research Personnel; Resources; Safety; Source; Testosterone; Treatment Efficacy; United States National Institutes of Health; Visit; men; open label

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.

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。 这是一项在睾酮缺乏男性中评价睾酮乳膏长期安全性和疗效的III期、多中心、开放标签、随访研究，已完成研究ARD-0403-004。 完成III期方案ARD-0403-004试验的所有受试者（最多150名男性） 将被邀请参加本扩展研究。 约20例受试者将从我中心入组。 本研究的目的是证明ARD-0403（一种睾酮乳膏）治疗被诊断为睾酮缺乏症的男性的长期安全性、耐受性和疗效。 每例受试者将在方案ARD-0403-004（IRB#12843-01）的“第12周结束”访视期间接受本研究的知情同意过程和入选阶段。 受试者将被充分告知所有相关程序及其潜在风险和益处;并将在之前解决任何问题 自愿签署研究知情同意书。 知情同意 讨论 将持续到受试者和获得知情同意的人员确信试验描述令人满意，并且受试者对其参与的后果有合理的理解。 将为潜在受试者提供充分的机会阅读知情同意书，并考虑他们是否愿意参与研究。 主研究第12周结束访视期间收集的信息将作为后续研究的基线指标。