CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - FEMALE SITES

CCTN - 避孕临床试验网络 - 女性站点

• 批准号: 10255790
• 负责人: DAVID TUROK
• 金额: $ 2.38万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-19 至 2020-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10255790
• 关键词: Basic Science; Chemicals; Clinical Research; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contracts; Development; Drug Kinetics; Estradiol; Female; Female Contraceptive Agents; Formulation; Goals; Grant; Health education; Hemorrhage; Lead; Male Contraceptive Agents; Methods; National Institute of Child Health and Human Development; Nestorone; Pattern; Phase; Phase IV Clinical Trials; Population Research; Reproductive Health; Safety; Site; Testing; United States National Institutes of Health; Woman; clinical research site; contraceptive efficacy; pre-clinical; side effect; synthetic peptide; welfare

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 proposed study will evaluate contraceptive efficacy , pharmacokinetics, bleeding patterns and safety and side effects of a Nestorone & estradiol ring for women.

美国国立卫生研究院（NIH），尤尼斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD），是进行基础和临床研究以开发新的避孕药具和评估现有避孕方法和生殖健康的牵头联邦机构。1968年，卫生、教育和福利部长在国家排雷中心内设立了人口研究中心，其重要目标是通过合同和赠款开发新的避孕药具。在预防和控制方案内，避孕和生殖健康分支处长期以来一直支持几个临床前避孕测试设施， 用于合成化学品和合成肽制剂的设施。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。目前的CCTN已经进行了女性和男性避孕方法的I期、II期和III期临床试验。随着CCTN的重新竞争，临床研究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。 这项研究将评估避孕效果，药代动力学，出血模式和安全性和妇女的雌二醇环的副作用。