CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE

CCTN - 避孕临床试验网络 - 核心 - 女性

• 批准号: 9304909
• 负责人: MITCHELL CREININ
• 金额: $ 1.85万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-26 至 2017-06-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9304909
• 关键词: Chemicals; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contracts; Development; Devices; Female; Female Contraceptive Agents; Formulation; Goals; Grant; Gynecologic; Health education; Lead; Leiomyoma; Methods; National Institute of Child Health and Human Development; Pharmaceutical Preparations; Pharmacotherapy; 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; novel therapeutics; 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, 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 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.

美国国立卫生研究院 (NIH) 尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 是负责进行基础临床研究以开发新避孕药并评估现有避孕和生殖健康方法的主要联邦机构。 NICHD 内的人口研究中心 (CPR) 于 1968 年由健康教育和福利部长建立，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 范围内，避孕和生殖健康部门 (CRHB) 长期以来一直支持多个临床前避孕测试设施以及合成化学和合成肽制剂设施。 为了进一步扩大其避孕药具开发能力，CRHB于1996年建立了NICHD避孕药具临床试验网络（CCTN）。目前CCTN已开展避孕方法的I、II、III期临床试验。 随着 CCTN 的重新竞争，临床中心将对各种新的或现有的女性避孕方法进行 I 期、II 期、III 期和 IV 期临床试验。 该合同的目的是在 I、II、III 和 IV 期试验中系统评估新型女性避孕药物和装置以及妇科疾病（如子宫内膜异位症或平滑肌瘤）的安全性和有效性。