CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE

CCTN - 避孕临床试验网络 - 核心 - 女性

• 批准号: 8887060
• 负责人: CAROLYN L WESTHOFF
• 金额: $ 2.54万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-06-26 至 2015-06-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8887060
• 关键词: Basic Science; Chemicals; Child; Child health care; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contracts; Development; Devices; Drug Formulations; Female; Female Contraceptive Agents; Goals; Grant; Gynecologic; Health education; Human Development; Institutes; Lead; Leiomyoma; Male Contraceptive Agents; Methods; National Institute of Child Health and Human Development; Pharmaceutical Preparations; Phase; Population Research; Protocols documentation; Reproductive Health; Safety; Site; Social Welfare; Testing; United States Food and Drug Administration; United States National Institutes of Health; Woman; base; clinical research site; clinical trial phase II/III/IV; drug candidate; endometriosis; pre-clinical; research and development; synthetic peptide; treatment trial

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 and clinical research to develop new contraceptives and to evaluate existing methods of contraception and reproductive health. The Center for Population Research (CPR), within NICHD, was established in 1968 by the Secretary of Health Education and Welfare, with 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. To further expand their contraceptive development capabilities, in 1996 CRHB established the NICHD Contraceptive Clinical Trials Network (CCTN). The current CCTN has conducted Phase I, II, and III clinical trials of both female and male contraceptive methods. 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)，即尤尼斯·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内的人口研究中心由卫生、教育和福利部长于1968年建立，其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 合成化学品和合成肽配方的设施。为了进一步扩大他们的避孕开发能力，CRHB于1996年建立了NICHD避孕临床试验网络(CCTN)。目前CCTN已经对女性和男性避孕方法进行了I、II和III期临床试验。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。 这份合同的目的是在I、II、III和IV期试验中系统地评估新型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。