CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE
CCTN - CONTRACEPTIVE CLINICAL TRIALS NETWORK - CORE - FEMALE
批准号:
8261617
负责人:
CRAIG FRANKLIN
金额:
$8.59万
依托单位国家:
美国
项目类别:
财政年份:
2011
资助国家:
美国
项目状态:
已结题
起止时间:
2011-04-01 至 2013-03-31
关键词:
Adverse effectsAdvisory CommitteesAgeClinicalClinical TrialsClinical Trials NetworkConduct Clinical TrialsConsultationsContraceptive AgentsContraceptive methodsContractorContractsDataDevelopmentDevicesDoseDrug KineticsEnrollmentEstradiolFemaleFemale Contraceptive AgentsGoalsGynecologicHemorrhageHuman ResourcesInterventionMale Contraceptive AgentsMethodsMissionNational Institute of Child Health and Human DevelopmentNestoroneNotificationObesityPatternPharmaceutical PreparationsPhasePopulationPrincipal InvestigatorProgestinsProtocols documentationPublic HealthRandomizedResearchResearch DesignRiskRisk FactorsSafetySiteSpecific qualifier valueThromboembolismVaginal RingVenousWomanbasecontraceptive effectivenesscontraceptive efficacydrug candidateprogramsprotocol developmentreproductivetreatment trialunintended pregnancy
中文摘要
NICHD的避孕临床试验网络对各种新的女性和男性避孕方法进行I、II和III期临床试验。该合同的目的是让CCTN承包商进行女性避孕临床试验,进行妇科疾病的治疗试验,并根据不确定交付/不确定数量(IDIQ)合同在任务订单的基础上制定研究方案。
英文摘要
The NICHD's Contraceptive Clinical Trials network conducts Phase I, II and III clinical trials of a wide variety of new female and male contraceptive methods. The objective of this contract is for CCTN contractors to conduct female contraceptive clinical trials, conduct treatment trials of gynecologic conditions, and to develop research protocols on a task Order basis under an Indefinite Delivery/Indefinite Quantity (IDIQ) contract.
There is a demand for new methods of contraception that can provide effective protection against unintended pregnancy as well as reduce the risk of venous thromboembolism (VTE), particularly for obese women. A new vaginal ring that can deliver a high dose progestin (Nestorone) and a low dose of estradiol (E2) may provide effective and safe contraception for women. The objective of the dose finding study is to identify a dose that can provide reliable contraception and acceptable bleeding patterns for up to 6 months of use.
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会议论文
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批准号:8338744
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资助金额:$77.53万
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资助金额:$77.53万
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批准号:8351335
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资助金额:$77.53万
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财政年份:2001
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负责人:CRAIG FRANKLIN
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依托单位:
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批准号:8351334
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资助金额:$77.53万
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财政年份:--
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依托单位:
海外基金