CCTN - CONTRACEPTIVE CLINICAL TRIAL NETWORK -- FEMALE SITES

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) 是开展基础和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（CCTN）。目前CCTN已开展女性和男性避孕方法的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。 本合同的目的是在I、II、III期临床试验中系统评价新型女性避孕药物和器械以及妇科疾病（如子宫内膜异位症或平滑肌瘤）的安全性和有效性，

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 clinical trial,