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

ARD-0403 功效和安全性的 III 期开放标签研究

• 批准号: 7952253
• 负责人: RONALD Sherwin SWERDLOFF
• 金额: $ 13.12万
• 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/7952253
• 关键词: Adverse event; Androgens; Biochemistry; Clinical; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Data; Dose; Electrocardiogram; Enrollment; Funding; Grant; Hematology; Hormones; Informed Consent; Institution; Laboratories; Maintenance; Patients; Pharmaceutical Preparations; Phase; Physical Examination; Process; Prostate; Reaction; Research; Research Personnel; Resources; Safety; Serious Adverse Event; Serum; Site; Source; Testosterone; Titrations; United States National Institutes of Health; digital; men; open label; rectal; safety study; treatment duration

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).

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III期、开放标签、剂量滴定、多中心研究。 滴定被定义为逐渐调整药物剂量直至达到预期效果的过程。 预计将有多达150名睾酮缺乏的男性参加这项研究。 他们每人每天将接受28次2.25 g ARD-0403的应用。 治疗28天后，如果睾酮水平不在参考范围内（300- 700 ng/dL），则将滴定ARD-0403的剂量，如果血清睾酮水平低于300 ng/dl，则将剂量增加2.25 g至4.5 g，如果水平高于700 ng/dl，则将剂量降低至1.5 g。 在患者进入12周维持期之前，可以进行进一步的剂量滴定。 在参与研究之前，潜在受试者将经历“入选阶段”，以确定他们是否有资格参与研究。该阶段将包括知情同意过程、当前雄激素治疗的洗脱（如适用）、体格检查（包括直肠指检以检查前列腺大小）、心电图（ECG）、安全性实验室评估（包括PSA、血液学和血清激素水平）。 受试者需要在入组研究之前至少两次记录血清总睾酮水平<250 ng/dL。 将通过评价收集的不良事件、严重不良事件（SAE）、ECG、生命体征、给药部位反应和临床实验室参数（生化和血液学）的安全性数据来评估研究药物的安全性。