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

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 的使命是为女性和男性开发安全有效的避孕药具。避孕临床试验网络（CCTN）的建立是为了向合格的场所提供进行新产品临床试验的能力，其中包括统计和临床协调中心（SCCC）。本任务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，该临床试验旨在评估用于男性避孕的奈斯托酮和睾酮组合凝胶的日常应用。目前男性的选择仅限于可逆避孕的避孕套或可逆性非常有限的输精管结扎术。对男性避孕新选择的需求日益增长。因此，NICHD 制定了一项开发用于男性避孕的新型激素药物的计划。初步研究已经完成，以证明首次人体安全性、重复剂量的促性腺激素抑制活性以及证明这些药物抑制精子产生的长期剂量。评估过程结束时，决定进行药物开发，以证明夫妻的避孕功效。当前 11B 期研究 CCN0l 7 的目标是证明男性伴侣使用该产品时的安全性、精子抑制和避孕功效。它要求两个主要男性站点招募大量夫妇，并在获得 NICHD 和 Fogarty International 的批准以及国务院的许可后，将分包合同授予在初步审查时已通过资格预审的国际站点，以选择 CCTN 站点进行男性避孕评估。 SCCC 招募了分包合作伙伴，向适当的监管机构提供监管援助，并监测国际站点的临床试验活动。招生目标已达到，招募已停止；所有剩余的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以及与研究相关的所有活动的协调。 SCCC 将继续协调和监督 Nestorone 睾酮凝胶组合作为新型男性避孕产品的多中心临床试验。所有站点将继续向 SCCC 传输数据。研究完成后，SCCC 将收集数据并进行数据分析，并准备一份适合支持监管指南的临床研究报告，以寻求 FDA 最终批准该新药。拟议的任务订单将提供持续的临床试验实施、监督和监测、数据分析和最终临床研究报告，以支持监管部门批准用于男性避孕的新产品。 范围 提供统计和临床协调以及多中心临床试验的监测，包括与方案变更、后勤支持、数据收集、数据库准备、数据分析和最终准备男性避孕新产品临床试验的临床研究报告相关的服务和支持。

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.