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

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510k、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。 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。

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. 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.