CCTN - COORDINATION OF CLINICAL TRIALS OF NESTORONE TESTOSTERONE GEL FOR MALE CONTRACEPTION

CCTN - 男性避孕用雀酮睾酮凝胶临床试验的协调

• 批准号: 10788176
• 负责人: CLINT DART
• 金额: $ 24.18万
• 依托单位: HEALTH DECISIONS INC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-18 至 2023-07-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10788176
• 关键词: Androgens; Archives; Case Report Form; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Contraceptive methods; Data; Data Analyses; Data Collection; Data Management Resources; Databases; Development; Dose; Drug usage; Enrollment; Gel; Goals; Gonadotropins; Hormonal; Institutional Review Boards; Male Contraceptive Agents; Monitor; Monitoring Clinical Trials; Multi-Institutional Clinical Trial; National Institute of Child Health and Human Development; Nestorone; Patients; Pharmaceutical Preparations; Preparation; Production; Protocols documentation; Reporting; Research Personnel; Safety; Services; Site; Spermatogenesis; Testosterone; Visit; Work; androgenic; contraceptive efficacy; diaries; first-in-human; follow-up; medication safety; meetings; men; novel; programs; protocol development; recruit; research clinical testing; sperm cell

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.

NICHD有一个开发用于男性避孕的新型孕激素和雄激素药物的项目。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可交付成果，这些临床试验旨在评价促孕雄激素药物，以确定安全性和精子抑制活性，从而证明这类男性试验用药物的避孕有效性。确定药物首次人体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，以确定药物是否会抑制精子的产生 为临床试验提供统计和临床协调以及监查，包括与方案制定、后勤支持、研究者会议、数据收集、数据库准备、数据分析和编写选定男性避孕产品临床试验的临床研究报告相关的服务和支持。