EVALUATION OF THE PHARMACOKINETIC PROFILE, EFFECTS ON THE MECHANISMS

药代动力学特征的评估以及对机制的影响

• 批准号: 8755662
• 负责人: ERIN ALLEN
• 金额: $ 66.98万
• 依托单位: HEALTH DECISIONS, INC.
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-28 至 2016-09-27
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8755662
• 关键词: Age; Anti-HIV Agents; Child; Child health care; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Companions; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Data; Data Analyses; Desogestrel; Development; Devices; Drug Combinations; Drug Formulations; Drug Kinetics; Effectiveness; Enrollment; Ensure; Equipment; Evaluation; Good Clinical Practice; Government; Health Benefit; Hemorrhage; Human Development; Human Resources; Individual; Infection; Institutes; International; Methods; Mission; Monitor; National Institute of Child Health and Human Development; Nestorone; Non obese; Obesity; Pattern; Pharmaceutical Preparations; Population; Pregnancy; Prevention; Progestins; Protocols documentation; Public Health; Qualifying; Recording of previous events; Records; Regulation; Reporting; Risk; Safety; Services; Site; Thromboembolism; Time; Venous; Woman; Work; clinical research site; contraceptive efficacy; follow-up; improved; reproductive; symposium

The National Institute of Child Health and Human Development (NICHD) has a mission to develop safe and effective contraceptives for women, including obese women and women who may be at risk ofHIV infection. Obesity is the number one public health issue facing the US population and is an independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to develop effective contraception for obese woman that does not increase the risk ofVTE. The development ofMPTs for prevention of both pregnancy and acquisition ofHIV infection requires evaluation of a combination of drugs in a single formulation or device. Each individual drug will have to be evaluated in the presence of the companion drug(s) in order to ensure that the release rate, effectiveness and safety are not compromised by the presence of another agent. The final product should be effective for contraception and ideally would also have a theoretically lower risk ofVTE especially for obese women. Although LNG has had the longest and widest history of providing effective contraception in a variety of formulations, newer progestins such as desogestrel and Nestorone may provide safe and effective contraception with improved bleeding patterns or other health benefits. Alternatively, non-hormonal contraceptive drugs may provide an opportunity to be able to be combined with anti-HIV drugs and provide dual purpose protection.

美国国家儿童健康与人类发展研究所（NICHD）的使命是为妇女（包括肥胖的妇女和可能处于感染风险的妇女）开发安全有效的避孕药具。肥胖是美国人口面临的第一公共卫生问题，是静脉血栓栓塞（VTE）的独立风险。因此，公共卫生需要为肥胖女性开发有效的避孕，而肥胖女性不会增加VETE的风险。预防妊娠和摄取感染的收入的发展需要评估单个配方或装置中药物的组合。必须在存在伴随药物的情况下评估每种药物，以确保其他药物的存在不会损害释放率，有效性和安全性。最终产品应有效地避孕，理想情况下也将具有VETE的风险降低，尤其是对于肥胖女性而言。尽管液化天然气在各种配方中提供有效的避孕措施的历史最长，最广，但较新的孕激素（如desogestelel和Nestorone）可以提供安全有效的避孕，并改善出血模式或其他健康益处。另外，非荷尔蒙避孕药可能会为能够与抗HIV药物结合并提供双重目的保护提供机会。