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.

尤妮斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD）的一项使命是为妇女和男子开发安全有效的避孕药具。建立了避孕药临床试验网络（CCTN），以使合格的研究中心能够进行新产品的临床试验，其中包括一个统计和临床协调中心（SCCC）。本任务指令的目的是开展所需的工作，并提供与临床试验相关的适当支持服务，该临床试验旨在评价用于男性避孕的Nestorone和Teastorone复方凝胶的日常应用。目前，男性的选择仅限于使用避孕套进行可逆性避孕，或使用输精管结扎术进行可逆性非常有限的避孕。越来越需要男性避孕的新选择。因此，NICHD有一个开发男性避孕新激素药物的计划。初步研究已经完成，以证明首次在人的安全性，重复剂量的促性腺激素抑制活性，并证明药物抑制精子生成的长期剂量。在评价过程结束时，决定继续开发药物，以证明夫妇避孕的功效。目前的11B期研究CCN 017的目标是证明当男性伴侣使用该产品时的安全性、精子抑制和避孕功效。它要求大量夫妇被招募到两个主要的男性研究中心，并在得到国家排雷中心和Fogarty国际的批准以及国务院的批准后，将分包合同授予在初步审查时已预先获得资格的国际研究中心，以选择CCT N研究中心进行男性避孕评价。SCCC招募了临床试验机构的合作伙伴，为相应的监管机构提供监管协助，并监测国际研究中心的临床试验活动。已达到目标入组，因此招募已停止;所有剩余夫妇预计将完成当前方案中概述的研究的所有活动和阶段。该任务指令将支持临床试验和与研究相关的所有活动的协调。SCCC将继续协调和监测复方Nestorone Teastorone Gel作为一种新型男性避孕产品的多中心临床试验。所有研究中心将继续向SCCC传输数据。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，以寻求FDA对新药的最终批准。拟定任务指令将提供持续的临床试验实施、监督和监查、数据分析以及最终临床研究报告，以支持男性避孕用新型产品的监管批准。 范围 为多中心临床试验提供统计和临床协调以及监查，包括与方案变更、后勤支持、数据收集、数据库准备、数据分析以及最终编写男性避孕新药临床试验的临床研究报告相关的服务和支持。