CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE

CCTN - 避孕临床试验网络 - 核心 - 女性

• 批准号: 9525753
• 负责人: LIVIA WAN
• 金额: $ 1.28万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-06-26 至 2018-06-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9525753
• 关键词: Chemicals; Clinical Research; Clinical Trials Network; Conduct Clinical Trials; Contraceptive Agents; Contraceptive methods; Contracts; Devices; Female; Female Contraceptive Agents; Formulation; Goals; Grant; Gynecologic; Gynecology; Lead; Leiomyoma; Methods; Mission; National Institute of Child Health and Human Development; Obesity; Pharmaceutical Preparations; Phase; Phase IV Clinical Trials; Population Research; Protocols documentation; Reproductive Health; Risk; Safety; Testing; Thromboembolism; United States National Institutes of Health; Venous; Woman; clinical research site; endometriosis; pre-clinical; synthetic peptide; unintended pregnancy

The National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), is the lead Federal agency for the conduct of basic, clinical research to develop new contraceptives and to evaluate existing methods of contraception and reproductive health. The Center for Population Research (CPR), within NICHD has the important goal of developing new contraceptives through the use of contracts and grants. Within CPR, the Contraception and Reproductive Health Branch (CRHB) has long supported several preclinical contraceptive testing facilities as well as facilities for synthetic chemical and synthetic peptide formulation. With the recompetition of the CCTN, clinical sites will perform Phase I, II, III, and Phase IV clinical trials of a wide variety of new or existing female contraceptive methods. The purpose of this contract is to systematically evaluate the safety and efficacy of new female contraceptive drugs and devices as well as gynecologic conditions, such as endometriosis or leiomyoma, in Phase I, II, III, and IV trials

国家卫生研究院(NIH)，尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(NICHD)，是开展基础和临床研究、开发新避孕药具和评估现有避孕和生殖健康方法的联邦牵头机构。NICHD内的人口研究中心的重要目标是通过使用合同和赠款开发新的避孕药具。在CPR内，避孕和生殖健康处(CRHB)长期以来一直支持几个临床前避孕测试设施以及合成化学和合成肽配方设施。 随着CCTN的重新竞争，临床站点将对各种新的或现有的女性避孕方法进行I、II、III和IV期临床试验。 本合同的目的是在I、II、III和IV期试验中系统地评估新的女性避孕药和装置的安全性和有效性以及妇科疾病，如子宫内膜异位症或子宫肌瘤。