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

CCTN - 女性避孕新产品的临床评价：功效研究

• 批准号: 10329859
• 负责人: STEPHANIE TEAL
• 金额: $ 1.73万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 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 2021-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329859
• 关键词: Age; Clinical; Clinical Practice Guideline; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Data; Data Analyses; Desogestrel; Development; Dose; Drug Kinetics; Enrollment; Estradiol; Ethinyl Estradiol; Event; Failure; Female; Female Contraceptive Agents; Formulation; Good Clinical Practice; Government; Health; Hemorrhage; Hormones; Injections; International; Intervention; Levonorgestrel; Menstruation; Methods; Mission; Monitor; National Institute of Child Health and Human Development; Nestorone; Obesity; Pattern; Phase; Population; Progestins; Protocols documentation; Public Health; Records; Recovery; Regulation; Resolution; Risk; Risk Factors; Safety; Sampling; Site; Testing; Time; Vaginal Ring; Woman; contraceptive effectiveness; contraceptive efficacy; effectiveness trial; efficacy study; follow-up; novel; protocol development; recruit; reproductive; research clinical testing; side effect; symposium; trial design; venous thromboembolism; xenoestrogen

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 professionally 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.

尤尼斯·肯尼迪·施赖弗国家儿童健康和人类发展研究所 (NICHD) 的使命是为女性（包括肥胖女性）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（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，且不会增加 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、雌二醇的产品或专业产品有可能大大降低 VTE 的风险。此类潜在更安全产品的一个例子是一种新型避孕阴道环 (CVR)，它可以提供连续剂量的奈斯托龙 (Nes) 和雌二醇 (E2)。 Nes/E2 环有潜力提供有效的长期避孕，无需日常干预。更安全的仅使用孕激素的方法的例子是左炔诺孕酮制剂（贴剂或注射剂）或去氧孕烯（丸剂）。为了评估新产品是否能有效避孕，NICHD避孕临床试验网络（CCTN）将进行临床试验。拟议的研究将在育龄妇女中进行，以评估这种新型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。如果出现严重的产品延迟或故障，重新确定优先级可能会导致在 CDDB 开发管道中测试不同的产品。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协议进行修改。