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.

国家儿童健康与人类发展研究所(NICHD)的使命是为妇女，包括肥胖妇女和可能有感染艾滋病毒风险的妇女开发安全有效的避孕药具。肥胖是美国民众面临的头号公共健康问题，也是静脉血栓栓塞症(VTE)的独立风险。因此，有公共卫生需要为肥胖妇女开发有效的避孕措施，而不增加VTE的风险。开发用于预防怀孕和感染艾滋病毒的MPTS需要对单一制剂或装置中的药物组合进行评估。每种单独的药物都必须在配套药物(S)存在的情况下进行评估，以确保释放速度、有效性和安全性不会因另一种药物的存在而受到影响。最终产品应该对避孕有效，理想情况下，理论上也会有较低的VTE风险，特别是对肥胖女性。虽然液化天然气在各种配方中提供有效避孕的历史最长、范围最广，但较新的孕激素，如地孕酮和雀巢酮，可能会提供安全有效的避孕措施，改善出血模式或其他健康益处。或者，非荷尔蒙避孕药可能提供一个机会，能够与抗艾滋病毒药物结合，并提供双重目的的保护。