CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

女性避孕新产品的临床评价

• 批准号: 10329657
• 负责人: MITCHELL CREININ
• 金额: $ 4.14万
• 依托单位: UNIVERSITY OF CALIFORNIA AT DAVIS
• 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/10329657
• 关键词: Age; Attitude; Biological; Blood specimen; Body mass index; Chlamydia; Clinical; Clinical Chemistry; Clinical Trials; Clinical Trials Network; Contraceptive Agents; Contraceptive History; Contraceptive methods; Counseling; Data; Desogestrel; Development; Dose; Drug Kinetics; Eligibility Determination; Enrollment; Ensure; Estradiol; Ethinyl Estradiol; Evaluation; Event; Excision; Exclusion Criteria; Failure; Female Contraceptive Agents; Formulation; Frequencies; Future; Gonorrhea; Guidelines; Height; Hematology; Hemorrhage; Hormones; Hour; Human Chorionic Gonadotropin; Informed Consent; Injections; Instruction; Intervention; Levonorgestrel; Measurement; Measures; Medical; Menstruation; Methods; Mission; National Institute of Child Health and Human Development; Nestorone; Obesity; Ovulation; Pap smear; Pattern; Pharmaceutical Preparations; Phase; Physiologic pulse; Pilot Projects; Population; Positioning Attribute; Pregnancy; Pregnancy Tests; Procedures; Progestins; Protocols documentation; Public Health; Randomized; Recording of previous events; Recovery; Regimen; Reporting; Reproductive History; Research Personnel; Rest; Risk; Risk Factors; Safety; Sampling; Schedule; Serum; Site; Specific qualifier value; System; Testing; Ultrasonography; Urine; Vaginal Ring; Visit; Weight; Woman; appropriate dose; base; birth control; breast exam; contraceptive efficacy; data exchange; demographics; efficacy study; follow-up; meetings; multi-site trial; novel; peripheral blood; protocol development; recruit; reproductive; research clinical testing; response; screening; side effect; technical report; venous thromboembolism; xenoestrogen

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.

临床试验网络-女性避孕新产品的临床评价：初步和疗效研究（PK） 尤尼斯·肯尼迪·施莱佛国家儿童健康和人类发展研究所（NICHD）的使命是为妇女，包括肥胖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卫生问题，也是静脉血栓栓塞症（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，而不会增加VTE的风险。含有合成雌激素炔雌醇的产品与VTE的剂量依赖性增加相关。含有天然激素、雌二醇或维生素B1的产品有可能降低VTE的风险。这种潜在的更安全的产品的一个例子是一种新的避孕阴道环（CVR），可以提供连续剂量的Nestorone（内斯）和雌二醇（E2）。内斯/E2环有可能提供有效的长期避孕，而无需每日干预。更安全的仅孕激素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，将在NICHD避孕临床试验网络（CCTN）中进行临床试验。该研究将在育龄妇女中进行，以评价这种新型避孕产品的避孕效果、药代动力学、出血模式以及安全性和副作用。如果出现重大产品延迟或故障，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方案进行修改。