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.

国家儿童健康和人类发展研究所 (NICHD) 的使命是为女性（包括肥胖女性和可能感染艾滋病毒的女性）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) 的独立风险。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。用于预防怀孕和艾滋病毒感染的 MPT 的开发需要对单一制剂或装置中的药物组合进行评估。每种药物都必须在伴随药物存在的情况下进行评估，以确保释放速率、有效性和安全性不会因另一种药物的存在而受到影响。最终产品应该能有效避孕，并且理论上也能降低静脉血栓栓塞风险，尤其是对于肥胖女性。尽管液化天然气在提供各种配方的有效避孕方面拥有最长和最广泛的历史，但较新的孕激素（例如去氧孕烯和奈斯托龙）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。或者，非激素避孕药可能提供与抗艾滋病毒药物联合使用并提供双重目的保护的机会。