CLINICAL EVALUATION OF NESTORONE/ESTRADIOL-RELEASING VAGINAL RING FOR FEMALE CONT

雌二醇释放阴道环对女性患者的临床评估

• 批准号: 8331042
• 负责人: MICHAEL THOMAS
• 金额: $ 48.56万
• 依托单位: UNIVERSITY OF CINCINNATI
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-03-31 至 2012-03-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8331042
• 关键词: Adverse effects; Advisory Committees; Age; Clinical; Clinical Trials; Clinical Trials Network; Conduct Clinical Trials; Consultations; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Data; Development; Devices; Dose; Drug Kinetics; Enrollment; Estradiol; Female; Female Contraceptive Agents; Goals; Gynecologic; Hemorrhage; Human Resources; Intervention; Male Contraceptive Agents; Methods; Mission; National Institute of Child Health and Human Development; Nestorone; Notification; Obesity; Pattern; Pharmaceutical Preparations; Phase; Population; Principal Investigator; Progestins; Protocols documentation; Public Health; Randomized; Research; Research Design; Risk; Risk Factors; Safety; Site; Specific qualifier value; Thromboembolism; Vaginal Ring; Venous; Woman; abstracting; base; contraceptive effectiveness; contraceptive efficacy; drug candidate; programs; protocol development; reproductive; research clinical testing; treatment trial; unintended pregnancy

Abstract: The NICHD's Contraceptive Clinical Trials network conducts Phase I, II and III clinical trials of a wide variety of new female and male contraceptive methods. The objective of this contract is for CCTN contractors to conduct female contraceptive clinical trials, conduct treatment trials of gynecologic conditions, and to develop research protocols on a task Order basis under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract. There is a demand for new methods of contraception that can provide effective protection against unintended pregnancy as well as reduce the risk of venous thromboembolism (VTE), particularly for obese women. A new vaginal ring that can deliver a high dose progestin (Nestorone) and a low dose of estradiol (E2) may provide effective and safe contraception for women. The objective of the dose finding study is to identify a dose that can provide reliable contraception and acceptable bleeding patterns for up to 6 months of use. 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.

摘要：NICHD的避孕临床试验网络对各种新的女性和男性避孕方法进行第一、第二和第三阶段的临床试验。该合同的目的是让CCTN承包商进行女性避孕临床试验，进行妇科疾病的治疗试验，并根据不确定交付/不确定数量（IDIQ）合同，以任务订单为基础制定研究方案。 需要新的避孕方法，可以提供有效的保护，防止意外怀孕，并减少静脉血栓栓塞（VTE）的风险，特别是对肥胖妇女。一种新的阴道环，可以提供高剂量的炔雌醇（Nestorone）和低剂量的雌二醇（E2），可以为妇女提供有效和安全的避孕。剂量探索研究的目的是确定可提供可靠避孕和可接受出血模式长达6个月使用的剂量。 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。