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

尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)的使命是为妇女和男子开发安全有效的避孕药具。避孕临床试验网络(CCTN)的建立是为了向符合条件的网站提供进行新产品临床试验的能力，包括统计和临床协调中心(SCCC)。本任务令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，该临床试验旨在评估用于男性避孕的雀巢和睾酮组合凝胶的日常应用。男性目前的选择仅限于用于可逆避孕的避孕套或用于可逆性非常有限的输精管结扎术。对男性避孕的新选择的需求越来越大。因此，NICHD有一个项目来开发用于男性避孕的新型激素药物。初步研究已经完成，证明了第一人安全性，重复剂量促性腺激素抑制活性，以及证明这些药物抑制精子生成的长期剂量。在评估过程结束时，决定继续进行药物开发，以证明夫妇之间的避孕效果。目前的11B期研究CCN017的目标是证明男性伴侣使用该产品时的安全性、精子抑制和避孕效果。它要求大量夫妇被招募到两个主要的男性地点，并在获得NICHD和Fogarty International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通过资格预审的国际地点，以选择CCTN地点进行男性避孕评估。SCCC招募了分包合作伙伴，与适当的监管机构一起提供监管协助，并监测国际地点的临床试验活动。已经实现了目标招生，招募工作已经停止；预计所有剩余夫妇都将完成目前议定书中概述的研究的所有活动和阶段。该任务订单将支持临床试验和与研究相关的所有活动的协调。SCCC将继续协调和监测作为一种新型男性避孕产品的联合睾丸酮凝胶的多点临床试验。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，并准备一份适合于支持监管指南的临床研究报告，以寻求FDA最终批准该新药。拟议的任务令将提供持续的临床试验进行、监督和监测、数据分析和最终临床研究报告，以支持监管机构批准用于男性避孕的新产品。 作用域 为多地点临床试验提供统计和临床协调以及监测，包括与方案更改、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临床研究报告有关的服务和支助。

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.