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

避孕临床试验网络（CCTN）的使命是制定方案并开展临床试验，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。协调避孕临床试验网络（CCTN）评估的新女性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）。每一种药物或装置都可能提供更低潜在严重副作用的避孕方法，尤其是肥胖女性。本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装置的避孕功效和安全性。除了临床评估和监测外，工作还包括数据库准备、数据分析和准备与批准方案相关的最终临床研究报告。该任务订单将协调方案开发、临床试验协调、监测、数据分析和指定有前景的新产品的临床研究报告。所有努力必须符合现行食品和药物管理局（FDA）规定的良好临床实践，最终的临床研究报告将作为支持FDA批准药物和器械的文件。

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