COORDINATION, MONITORING, FOLLOW-UP, AND EVALUATION OF A CLINICAL TRIAL OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION

用于男性避孕的雀酮睾酮凝胶临床试验的协调、监测、随访和评估

• 批准号: 10800827
• 负责人: CLINT DART
• 金额: $ 296.88万
• 依托单位: HEALTH DECISIONS INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2023-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10800827
• 关键词: Award; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical Trials Network; Conduct Clinical Trials; Contraceptive Agents; Contraceptive methods; Couples; Data; Data Analyses; Data Collection; Databases; Dose; Enrollment; Evaluation; Food and Drug Administration Drug Approval; Gel; Goals; Gonadotropins; Good Clinical Practice; Guidelines; Hormonal; International; Male Contraceptive Agents; Mission; Monitor; Monitoring Clinical Trials; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Nestorone; New Drug Approvals; Pharmaceutical Preparations; Phase; Preparation; Process; Production; Protocols documentation; Qualifying; Regulation; Reporting; Safety; Services; Site; Specific qualifier value; Testosterone; Time; Vasectomy; Woman; Work; condoms; contraceptive efficacy; data exchange; drug development; first-in-human; follow-up; male; men; novel; programs; recruit; research clinical testing; sperm cell

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women and for men. The Contraceptive Clinical Trials Network (CCTN) was established to provide qualified sites the ability to perform clinical trials of new products, including a Statistical and Clinical Coordinating Center (SCCC). The purpose of this Task Order is to conduct work required and to provide the appropriate support services associated with a clinical trial designed to evaluate the daily application of a Nestorone and Testosterone combination gel for male contraception. The current options for men are limited to condoms for reversible contraception or vasectomy for contraception that has very limited reversibility. There is a growing need for new options for male contraception. Consequently, the NICHD has a program to develop novel hormonal drugs for male contraception. Preliminary studies have been completed to demonstrate first-in-man safety, repeat dose gonadotropin suppressive activity, and longer-term dosing that prove that the drugs suppress sperm production. At the conclusion of that evaluation process, a decision was made to pursue drug development to demonstrate contraceptive efficacy in couples. The goal of the current Phase 11B study, CCN0l 7, is to demonstrate safety, sperm suppression and contraceptive efficacy when the product is used by the male partner. It has required large numbers of couples to be recruited to the two main male sites, and with approval from NICHD and Fogarty International as well as State Department clearance, awarded subcontracts to the international sites that had pre-qualified at the time of initial review for selection of CCTN sites for male contraceptive evaluation. The SCCC recruited subcontract partners to provide regulatory assistance with the appropriate regulatory agencies and to monitor clinical trial activity at the international sites. Target enrollment has been achieved such that recruitment has ceased; all remaining couples are expected to complete all activities and phases of the study as outlined in the current protocol. This task order will support the coordination of the clinical trial and all of activities associated with the study. The SCCC will continue to coordinate and monitor the multi-site clinical trial of the combination Nestorone Testosterone Gel for use as a novel male contraceptive product. All sites will continue to transfer data to the SCCC. Upon study completion, the SCCC will collect the data and perform data analysis as well as prepare a clinical study report suitable to support regulatory guidelines to pursue eventual FDA approval of the new drug. The proposed task order will provide continued clinical trial conduct, oversight and monitoring, data analysis and a final clinical study report for the supporting regulatory approval of the novel product for male contraception. SCOPE To provide statistical and clinical coordination as well as monitoring of a multi-site clinical trial, including services and support related to protocol changes, logistical support, data collection, database preparation, data analysis and eventual preparation of clinical study report of the clinical trial of a new product for contraception in men.

Eunice Kennedy Shriver国家儿童健康与人类发展研究所（NICHD）的使命是为妇女和男性开发安全有效的避孕药具。建立了避孕临床试验网络（CCTN），以提供合格的地点，能够对新产品进行临床试验，包括统计和临床协调中心（SCCC）。该任务订单的目的是进行所需的工作，并提供与临床试验相关的适当支持服务，旨在评估Nestorone和睾丸激素组合凝胶每天应用男性避孕。当前男性的选择仅限于可逆避孕或输精管切除术以进行避孕的避孕套，这些避孕措施的可逆性非常有限。对男性避孕的新选择越来越需要。因此，NICHD具有开发新型荷尔蒙药物以用于男性避孕药的计划。已经完成了初步研究，以证明人类的安全性，重复促性腺激素抑制活性以及长期给药，证明这些药物会抑制精子的产生。在该评估过程的结论结束时，做出了决定进行药物开发以证明夫妻避孕功效的决定。当前11B研究CCN0L 7的目的是在男性伴侣使用产品时证明安全性，精子抑制和避孕功效。它要求将大量夫妇招募到两个主要的男性站点，并在NICHD和Fogarty International以及国务院的批准下批准，并将其分包给了国际遗址，这些国际地点是在最初审查时预先审查的，用于选择CCTN站点的男性避孕措施评估。 SCCC招募了分包合作伙伴，以在适当的监管机构提供监管援助，并监视国际地点的临床试验活动。已经实现了目标入学率，以使招聘停止；预计所有其余的夫妇将完成研究的所有活动和阶段，如当前协议中所述。该任务顺序将支持临床试验和与研究相关的所有活动的协调。 SCCC将继续协调和监测Nestorone睾丸激素凝胶组合的多站点临床试验，以用作新型的男性避孕产品。所有站点将继续将数据传输到SCCC。完成研究完成后，SCCC将收集数据并进行数据分析，并准备适合支持监管指南的临床研究报告，以最终获得FDA的新药批准。拟议的任务顺序将提供持续的临床试验，监督和监测，数据分析以及最终的临床研究报告，以支持新型男性避孕产品的监管批准。 范围 提供统计和临床协调以及监测多站点临床试验，包括与协议变更，后勤支持，数据收集，数据库准备，数据分析以及最终制备新产品临床试验的临床研究报告有关男性避孕的新产品的临床研究报告。