CCTN - EVALUATION OF THE PHARMACOKINETIC PROFILE, EFFECTS ON THE MECHANISMS

CCTN - 药代动力学特征的评估，对机制的影响

• 批准号: 10710521
• 负责人: ERIN ALLEN
• 金额: $ 38.4万
• 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: 2013-09-24 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10710521
• 关键词: Age; Anti-HIV Agents; Clinical; Clinical Practice Guideline; Clinical Research; Clinical Trials; Companions; Contraceptive Agents; Contraceptive methods; Contractor; Contracts; Data; Desogestrel; Development; Devices; Drug Combinations; Drug Kinetics; Effectiveness; Enrollment; Ensure; Equipment; Evaluation; Formulation; Good Clinical Practice; Government; Health Benefit; Hemorrhage; Human Resources; Individual; Infection; International; Methods; Mission; Monitor; Multicenter Trials; National Institute of Child Health and Human Development; Nestorone; Non obese; Obesity; Pattern; Pharmaceutical Preparations; Population; Pregnancy; Prevention; Progestins; Protocols documentation; Public Health; Recording of previous events; Records; Regulation; Reporting; Risk; Safety; Services; Site; Time; Woman; Work; clinical research site; contraceptive efficacy; follow-up; improved; reproductive; symposium; venous thromboembolism

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的一项使命是为妇女，包括肥胖妇女和可能感染艾滋病毒的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，是静脉血栓栓塞症（VTE）的独立风险。因此，公共卫生需要为肥胖妇女开发有效的避孕方法，而不会增加静脉血栓栓塞的风险。开发用于预防怀孕和艾滋病毒感染的MPT需要评估单一配方或设备中的药物组合。必须在存在伴随药物的情况下对每种药物进行评价，以确保释放速率、有效性和安全性不会因存在另一种药物而受到影响。最终产品应该是有效的避孕，理想情况下也将有一个理论上较低的风险静脉血栓栓塞，特别是对肥胖妇女。虽然LNG在各种配方中提供有效避孕方面具有最长和最广泛的历史，但较新的孕激素如去氧孕烯和Nestorone可能提供安全有效的避孕，改善出血模式或其他健康益处。或者，非激素避孕药物可能提供了一个与抗艾滋病毒药物联合使用并提供双重保护的机会。