CCTN - COORDINATION OF CLINICAL TRIALS OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

避孕临床试验网络(CCTN)的任务是制定方案和进行临床试验，以协助产品开发，最终目标是为妇女，包括肥胖妇女等特殊人群提供有效和安全的避孕措施。协调由避孕临床试验网络(CCTN)评估的女性新产品临床研究的方案制定、临床试验、监测和数据分析，包括统计和临床协调中心(SCCC)。每种药物或装置都可能提供潜在严重副作用较低的避孕措施，特别是肥胖女性。该任务令的目的是获得有效和可靠的数据，以确定用于肥胖和非肥胖育龄妇女的研究药物和器具的避孕效果和安全性。除了临床评估和监测外，这项工作还包括数据库准备、数据分析和与批准的方案相关的最终临床研究报告的准备。该任务订单将协调指定的有前景的新产品的方案开发、临床试验协调、监测、数据分析和临床研究报告。所有努力必须符合当前食品和药物管理局(FDA)规定的良好临床实践，最终临床研究报告将作为支持FDA批准药物和设备的文件。 示例包括： 1.小剂量口服孕激素受体调节剂(PRMs)，如醋酸利培酮(UPA)，可抑制排卵，引起闭经。 2.雀巢/雌三醇阴道环 3.铜质宫内节育器伴发出血 4.丁酸左炔诺孕酮注射剂方法

The mission of the Contraceptive Clinical Trials Network (CCTN) is to develop protocols and conduct clinicals trials that will assist in product development with the end goal to provide effective and safe contraception for women, including special populations such as obese women.Coordinate protocol development, clinical trials, monitoring, and data analysis of clinical studies of new female products evaluated by Contraceptive Clinical Trials Network (CCTN), including a Statistical and Clinical Coordinating Center (SCCC). Each drug or device possibly will provide contraception with lower potentially serious side effects, especially obese women. The objective of this task order is to obtain valid and reliable data to determine the contraceptive efficacy and safety of investigational drugs and devices for use in obese and non-obese women of reproductive age. In addition to clinical evaluation and monitoring, the work consists of database preparation, data analysis and preparation of the final Clinical Study Reports associated with the approved protocols. This task order will coordination of protocol development, clinical trial coordination, monitoring, data analysis and clinical study reports for designated promising new products. All efforts must be in compliance with Good Clinical Practice as specified by the current Food and Drug Administration (FDA) regulations and the final Clinical Study Reports will serve as documents in support of FDA approval of the drugs and devices. Examples include: 1. Low dose oral progesterone receptor modulator (PRMs), such as ulipristal acetate (UPA), which inhibits ovulation and causes amenorrhea. 2. Nestorone/Etradiol vaginal ring 3. Copper IUD, associated with bleeding 4. Levonorgestrel butanoate injectable method