CCTN - CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION: PILOT AND EFFICACY STUDY

CCTN - 女性避孕新产品的临床评价：试点和功效研究

• 批准号: 8933135
• 负责人: CAROLYN L WESTHOFF
• 金额: $ 42.33万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 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 2017-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8933135
• 关键词: Adverse effects; Advisory Committees; Age; Clinical; Clinical Trials; Clinical Trials Network; Consultations; Contraceptive Agents; Contraceptive methods; Contracts; Data; Development; Devices; Dose; Drug Kinetics; Enrollment; Estradiol; Female Contraceptions; Female Contraceptive Agents; Goals; Gynecologic; Hemorrhage; Human Resources; Intervention; Mission; National Institute of Child Health and Human Development; Nestorone; Notification; Obesity; Pattern; Pharmaceutical Preparations; Phase; Population; Principal Investigator; Protocols documentation; Public Health; Randomized; Research Design; Risk; Risk Factors; Safety; Serum; Site; Specific qualifier value; Testing; Thromboembolism; Vaginal Ring; Venous; Woman; base; contraceptive effectiveness; contraceptive efficacy; dosage; drug candidate; novel; programs; protocol development; reproductive; research clinical testing

The contract network of clinical trial sites will evaluate systematically the safety and efficacy of new female contraceptive drugs and devices as well as drug treatments of gynecologic conditions in Phase I, II, and III clinical trials. The study design will be specified in each Request for Task Order Proposals. The results of these clinical trials would be the basis for advancing candidate drugs and devices through development, with the ultimate goal of submission to the FDA in support of a New Drug Application (NDA), Premarket notification 510k, Premarket Approval (PMA) or Investigational Device Exemptions (IDE). Based upon site capabilities, the Principal Investigator (and other site personnel as appropriate) shall participate in the development of protocols in cooperation with personnel from the Statistical and Clinical Coordinating Center and with NICHD program personnel. The candidate protocols, drugs or devices to be evaluated clinically under this contract shall be selected by the NICHD with consultation from the Scientific Advisory Committee of the CCTN. The NICHD has a mission to develop safe and effective contraceptives for women, including obese women. Obesity is the number one public health issue facing the US population and is independent risk factor for venous thromboembolism (VTE). Therefore, there is a public health need to develop effective contraception for obese woman that does not increase the risk of VTE. The Nes/E2 ring has the potential to provide effective long term contraception without the need for daily intervention. The proposed study will be conducted in women of reproductive age in order to evaluate contraceptive efficacy, pharmacokinetics, bleeding patterns, and the safety and side effects of this new contraceptive product. The enrolled subjects will be randomized into three treatment groups who will receive rings containing Nes in combination with different doses of E2. The objectives is to obtain valid and reliable data to determine the contraceptive effectiveness, pharmacokinetics, bleeding patterns, side effects and safety of vaginal rings containing Nes and Es in women of reproductive age to identify a dose that can provide reliable contraception and acceptable bleeding patterns for up to 6 months of use.The proposed study will evaluate contraceptive efficacy , pharmacokinetics, bleeding patterns and safety and side effects of a Nestorone & estradiol ring for women.

临床试验中心的合同网络将在I、II和III期临床试验中系统评价新的女性避孕药物和器械以及妇科疾病药物治疗的安全性和有效性。研究设计将在每个任务订单提案请求中详细说明。这些临床试验的结果将是通过开发推进候选药物和器械的基础，最终目标是提交给FDA，以支持新药申请（NDA）、上市前通知510 k、上市前批准（PMA）或研究器械豁免（IDE）。根据研究中心的能力，主要研究者（和其他研究中心人员，如适用）应与统计和临床协调中心的人员以及NICHD项目人员合作参与方案的制定。根据本合同进行临床评价的候选方案、药物或器械应由NICHD在咨询CCTN科学咨询委员会后选择。NICHD的使命是为妇女，包括肥胖妇女开发安全有效的避孕药具。肥胖是美国人口面临的头号公共卫生问题，也是静脉血栓栓塞症（VTE）的独立危险因素。因此，公共卫生需要为肥胖女性开发有效的避孕方法，而不会增加VTE的风险。内斯/E2环有可能提供有效的长期避孕，而无需每日干预。该研究将在育龄妇女中进行，以评价这种新型避孕产品的避孕效果、药代动力学、出血模式以及安全性和副作用。入组的受试者将被随机分配到三个治疗组，这些治疗组将接受含有内斯的环与不同剂量的E2的组合。目的是获得有效和可靠的数据，以确定含有内斯和Es的阴道环在育龄妇女中的避孕有效性、药代动力学、出血模式、副作用和安全性，以确定可以提供可靠避孕和可接受的出血模式长达6个月使用的剂量。出血模式和安全性和副作用的一个Nestorone和雌二醇环的妇女。