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.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这是一项针对睾酮霜的长期安全性和有效性的 III 期、多中心、开放标签后续研究，对象是完成研究 ARD-0403-004 的睾酮缺乏男性。 所有完成 III 期方案 ARD-0403-004 试验的受试者（最多 150 名男性）将被邀请参加这项扩展研究。 我们中心将招收大约 20 名受试者。 该研究的目的是证明 ARD-0403（一种睾酮乳膏）治疗被诊断患有睾酮缺乏症的男性的长期安全性、耐受性和有效性。 每个受试者将在 ARD-0403-004 (IRB#12843-01) 方案的“第 12 周结束”访视期间经历本研究的知情同意流程和纳入阶段。 受试者将被充分告知所有相关程序及其潜在风险和益处；并在自愿签署研究知情同意书之前解决任何问题。 知情同意讨论将持续到受试者和获得同意的人都确信试验已得到令人满意的描述并且受试者对其参与的后果有合理的理解。 潜在受试者将有充足的机会阅读知情同意文件并考虑是否愿意参与研究。 主要研究第 12 周结束访视期间收集的信息将作为后续研究的基线测量。