CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

临床试验网络-女性避孕新产品的临床评估：PK的先导和有效性研究 尤尼斯·肯尼迪·施莱弗国家儿童健康和人类发展研究所(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。肥胖是美国民众面临的头号公共健康问题，也是静脉血栓栓塞症(VTE)的独立危险因素。因此，有公共卫生需要为肥胖妇女制定有效的避孕措施，而不增加VTE的风险。含有合成雌激素乙炔雌二醇的产品与VTE的剂量依赖性增加有关。含有天然激素、雌二醇或孕激素的产品患VTE的风险可能要低得多。这种潜在更安全的产品的一个例子是一种新的避孕阴道环(CVR)，它可以提供连续剂量的雀巢(NES)和雌二醇(E2)。NES/E2环有可能提供有效的长期避孕措施，而不需要日常干预。更安全的孕激素治疗方法的例子有左旋诺孕酮制剂(贴剂或注射剂)或地塞米松(药丸)。为了评估新产品是否对避孕有效，NICHD避孕临床试验网络(CCTN)将进行一项临床试验。这项拟议的研究将在育龄妇女中进行，以评估这种新避孕药的避孕效果、药代动力学、出血模式以及安全性和副作用。如果产品出现重大延迟或故障，重新确定优先级可能会导致在CDDB开发流程中测试不同的产品。在这种情况下，范围和目标保持不变，技术要求的细节将根据最新批准的议定书进行修改。

Clinical Trails Network - Clinical Evaluation of Novel Products for Female Contraception: Pilot and Efficacy Study with PK The Eunice Kennedy Shriver National Institute of Child Health and Human Development (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 an 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. Products containing the synthetic estrogen, ethinyl estradiol, have been associated with a dose­ dependent increase in VTE. Products containing the natural hormone, estradiol, or progestin­ only products have the potential for a much lower risk of VTE. One example of such potentially safer products is a new contraceptive vaginal ring (CVR) that can deliver a continuous dose of Nestorone (Nes) and estradiol (E2). The Nes/E2 ring has the potential to provide effective long term contraception without the need for daily intervention. Examples of safer progestin-only methods are levonorgestrel formulations (patch or injection) or desogestrel (pill). In order to evaluate if new products could be effective for contraception, a clinical trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). 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. In the event of substantial product delay or failure, reprioritization may result in testing of a different product in the CDDB development pipeline. In such cases, the scope and objectives remain the same and the specifics of the technical requirements will be modified according to the latest approved protocol.