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

CCTN - 女性避孕新产品临床试验的协调

基本信息

批准号：
10020278
负责人：
DART CLINT
金额：
$ 140.31万
依托单位：
HEALTH DECISIONS, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-13 至 2021-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10020278
关键词：
Acetates Age Amenorrhea Clinical Clinical Research Clinical Trials Clinical Trials Network Conduct Clinical Trials Contraceptive Agents Contraceptive methods Contracts Copper Data Data Analyses Data Collection Data Coordinating Center Databases Development Device Approval Devices Dose Estradiol Estrogens Evaluation Female Female Contraceptive Agents Food and Drug Administration Drug Approval Goals Good Clinical Practice Hemorrhage Injectable Internet Investigational Drugs Investigational New Drug Application Levonorgestrel Methods Mission Monitor Nestorone Non obese Obesity Oral Ovulation Pharmaceutical Preparations Preparation Progesterone Receptors Progestins Protocols documentation Regimen Regulation Reporting Research Risk Safety Site Specific qualifier value United States Food and Drug Administration Vaginal Ring Weight Woman Work clinical development contraceptive efficacy data management named group novel pill population health product development protocol development public health relevance reproductive research clinical testing side effect statistics task analysis

项目摘要

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

避孕临床试验网络（CCTN）的使命是制定方案并进行临床试验，以协助产品开发，最终目标是为女性（包括肥胖女性等特殊人群）提供有效和安全的避孕措施。协调避孕临床试验网络（CCTN）评估的新女性产品的临床研究方案制定、临床试验、监测和数据分析。包括统计和临床协调中心（SCCC）。每种药物或设备都可能提供具有较低潜在严重副作用的避孕措施，特别是肥胖女性。本任务指令的目的是获得有效和可靠的数据，以确定研究药物和器械用于肥胖和非肥胖育龄女性的避孕有效性和安全性。除临床评价和监查外，工作还包括数据库准备、数据分析和与获批方案相关的最终临床研究报告的准备。该任务指令将协调方案制定、临床试验协调、监查、数据分析和指定有前景的新产品的临床研究报告。所有工作必须符合现行美国食品药品监督管理局（FDA）法规规定的药物临床试验质量管理规范，最终临床研究报告将作为FDA批准药物和器械的支持文件。示例包括： 1. 低剂量口服孕酮受体调节剂（PRM），如醋酸乌利司他（UPA），可抑制排卵并导致闭经。 2. Nestorone/Etradiol阴道环 3. 铜宫内节育器，与出血相关 4. 一种丁酸左炔诺孕酮注射方法