COORDINATION OF CLINICAL TRIALS OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION

NICHD有一个项目，开发用于男性避孕的新型孕激素激素性药物。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交付成果，这些临床试验旨在评估孕激素雄激素药物，以确定安全性和精子抑制活性，从而证明这类研究产品对男性的避孕效果。确定这些药物的第一人安全性的初步试验已经完成。下一步是进行重复剂量的促性腺激素抑制活性和长期剂量，以确定这些药物是否会抑制精子生成。 提供统计和临床协调以及对临床试验的监测，包括与方案制定、后勤支助、调查员会议、数据收集、数据库编制、数据分析和编写男性部分避孕产品临床试验的临床研究报告有关的服务和支助。

The NICHD has a program to develop novel progestogenic androgenic hormonal drugs for male contraception. The purpose of this task order is to conduct work required and to provide the appropriate deliverables associated with clinical trials that are designed to evaluate progestogenic androgen drugs to determine safety and sperm suppressive activity leading to demonstration of contraceptive efficacy of this class of investigational products for men. The preliminary trials to determine first-in-man safety for the drugs have been completed. The next step is to conduct repeat dose gonadotropin suppressive activity and longer-term dosing to determine if the drugs will suppress sperm production To provide statistical and clinical coordination as well as monitoring of clinical trials, including services and support related to protocol development, logistical support, investigator meetings, data collection, database preparation, data analysis and preparation of clinical study reports of clinical trials of selected products for contraception in men.