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

临床试验点合同网络将系统评价新型女性避孕药物和器具的安全性和有效性，以及一、二、三期临床试验中妇科疾病的药物治疗。研究设计将在每个任务订单提案请求中指定。这些临床试验的结果将成为推进候选药物和器械开发的基础，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）。根据现场的能力，首席研究员（以及其他适当的现场人员）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估的候选方案、药物或设备应由NICHD在与CCTN科学咨询委员会协商后选择。NICHD的使命是为包括肥胖妇女在内的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健康问题，也是静脉血栓栓塞（VTE）的独立危险因素。因此，从公共卫生的角度来看，需要为肥胖妇女开发有效的避孕方法，而不会增加静脉血栓栓塞的风险。Nes/E2环有可能提供有效的长期避孕，而不需要每天干预。拟议的研究将在育龄妇女中进行，以评估这种新避孕产品的避孕功效、药代动力学、出血模式以及安全性和副作用。纳入的受试者将被随机分为三个治疗组，他们将接受含有Nes的环和不同剂量的E2。目的是获得有效和可靠的数据，以确定育龄妇女使用含有Nes和Es的阴道环的避孕效果、药代动力学、出血模式、副作用和安全性，以确定在长达6个月的使用中能够提供可靠避孕和可接受出血模式的剂量。这项拟议的研究将评估奈斯托酮和雌二醇环对女性的避孕功效、药代动力学、出血模式以及安全性和副作用。

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.