COORDINATION OF CLINICAL TRIALS 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

• 批准号: 10219874
• 负责人: CLINT DART
• 金额: $ 88.8万
• 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 2022-07-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10219874
• 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; Ensure; Gel; Goals; Gonadotropins; Hormonal; Institutional Review Boards; Investigation; Logistics; Male Contraceptive Agents; Monitor; Monitoring Clinical Trials; 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具有开发新型孕激素雄激素药物的计划，用于雄性避孕。该任务订单的目的是进行所需的工作，并提供与临床试验相关的适当可交付物，旨在评估孕激发雄激素药物，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功效。确定药物第一组安全的初步试验已完成。 下一步是进行重复剂量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 提供统计和临床协调以及监测临床试验的监测，包括与协议开发，后勤支持，研究者会议，数据收集，数据库准备，数据分析，数据分析和临床研究的临床研究报告所选产品临床试验的临床研究报告有关男性避孕产品的临床研究报告。