EVALUATION OF THE PHARMACOKINETIC PROFILE, EFFECTS ON THE MECHANISMS OF CONTRACEPTIVE EFFICACY AND SAFETY OF MULTIPURPOSE PREVENTION TECHNOLOGIES PROD

多用途预防技术产品的药代动力学特征、避孕功效和安全性机制的影响评价

• 批准号: 10248840
• 负责人: CLINT DART
• 金额: $ 60.02万
• 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 2022-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10248840
• 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; Technology; Time; Woman; Work; clinical research site; contraceptive efficacy; follow-up; improved; public health relevance; reproductive; symposium; venous thromboembolism

Abstract: 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.

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