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
基本信息
- 批准号:10710521
- 负责人:
- 金额:$ 38.4万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AgeAnti-HIV AgentsClinicalClinical Practice GuidelineClinical ResearchClinical TrialsCompanionsContraceptive AgentsContraceptive methodsContractorContractsDataDesogestrelDevelopmentDevicesDrug CombinationsDrug KineticsEffectivenessEnrollmentEnsureEquipmentEvaluationFormulationGood Clinical PracticeGovernmentHealth BenefitHemorrhageHuman ResourcesIndividualInfectionInternationalMethodsMissionMonitorMulticenter TrialsNational Institute of Child Health and Human DevelopmentNestoroneNon obeseObesityPatternPharmaceutical PreparationsPopulationPregnancyPreventionProgestinsProtocols documentationPublic HealthRecording of previous eventsRecordsRegulationReportingRiskSafetyServicesSiteTimeWomanWorkclinical research sitecontraceptive efficacyfollow-upimprovedreproductivesymposiumvenous thromboembolism
项目摘要
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。用于预防妊娠和HIV感染的MPTs的开发需要对单一制剂或装置中的药物组合进行评价。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。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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{{ truncateString('ERIN ALLEN', 18)}}的其他基金
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 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
CCTN - CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE
CCTN - 每日口服醋酸乌利司他的避孕功效和安全性
- 批准号:
8730338 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - MALE
CCTN - 避孕临床试验网络 - 核心 - 男性
- 批准号:
8749805 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
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:
10923774 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
CCTN - CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE
CCTN - 每日口服醋酸乌利司他的避孕功效和安全性
- 批准号:
10078224 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
MATERNAL VITAMIN D STATUS AND MEASURES OF NEONATAL BONE MINERAL CONT
母体维生素 D 状况和新生儿骨矿物质含量测量
- 批准号:
8749653 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
CCTN - CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE
CCTN - 每日口服醋酸乌利司他的避孕功效和安全性
- 批准号:
8744409 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
BIOMEDICAL ANALYSIS OF HUMAN BIOSPECIMENS FOR DIPHR
DIPHR 人体生物样本的生物医学分析
- 批准号:
8740710 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
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:
9915804 - 财政年份:2013
- 资助金额:
$ 38.4万 - 项目类别:
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