CLINICAL EVALUATION OF NOVEL PRODUCTS FOR FEMALE CONTRACEPTION

女性避孕新产品的临床评价

基本信息

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
项目类别：
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

项目摘要

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：PK 试验和疗效研究尤尼斯·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，也是一个独立的危险因素。因此，公共卫生需要为肥胖女性开发一种不会增加 VTE 风险的产品，其中含有合成雌激素乙炔雌二醇。含有天然激素、雌二醇或仅含孕激素的产品具有降低 VTE 风险的潜力，这种可能更安全的产品的一个例子是一种新型避孕阴道环 (CVR)。连续剂量的奈斯托酮 (Nes) 和雌二醇 (E2) Nes/E2 环有可能提供有效的长期避孕，而无需每日干预。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可以有效避孕，将在 NICHD 避孕临床试验网络 (CCTN) 中进行临床试验。育龄妇女，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。如果产品出现严重延迟或失败，可能会导致重新优先考虑。在这种情况下，范围和目标保持不变，并且技术要求的细节将根据最新批准的协议进行修改。