grant
A PHASE 2B STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION
Organization COLUMBIA UNIVERSITY HEALTH SCIENCESLocation NEW YORK, UNITED STATESPosted 29 Sept 2025Deadline 31 Dec 2028
NIHUS FederalResearch GrantFY2025Active Follow-upActive SitesAddressAdherenceAge YearsAgreementAwardClinic VisitsClinicalClinical EvaluationClinical InvestigatorClinical Practice GuidelineClinical ResearchClinical StudyClinical TestingClinical TrialsClinical Trials NetworkCollaborationsConduct Clinical TrialsContraceptionContraceptive AgentsContraceptive methodsContraceptivesContracting OpportunitiesContractorContractsCorlutinaCorluviteCyclogestD-NorgestrelDataData CollectionDepo-Medroxyprogesterone AcetateDevelopmentDevicesDoseDrug KineticsDrug PrecursorsDrugsEnrollmentEquipmentEstrogensEvaluationFamilyFecundabilityFecundityFemale ContraceptionFemale ContraceptionsFemale Contraceptive AgentsFemale ContraceptivesFertilityFertility ControlFormulationFosteringFundingGCP standardGestagenic AgentsGestagensGestationGestironGestoneGoalsGood Clinical PracticeGovernmentGovernment AgenciesHigh Risk WomanHuman ResourcesHydrolysisIRBIRBsImplantIncidenceIndividualInfrastructureInhibition of FertilizationInjectableInjectionsInstitutional Review BoardsInternationalIntramuscular InjectionsLeadLevonorgestrelLipo-LutinLuteohormoneLutocyclinLutocylin MLutogylLutromoneManpowerMedicationMedroxyprogesterone 17-AcetateMedroxyprogesterone AcetateMedroxyprogesteroni AcetasMensesMenstruationMethodsMethylacetoxyprogesteroneMetipregnoneModificationMonitorMoodsNICHDNational Institute of Child Health and Human DevelopmentNon obeseNonobeseObesityOral ContraceptivesOutcomeOvulationOvulation InhibitionOvulation SuppressionPK/PDParticipantPb elementPharmaceutical PreparationsPharmacodynamicsPharmacokineticsPhasePregnancyPreparednessPrivate SectorPrivatizationPro-DrugsProdrugsProgestagenic AgentsProgestasertProgestational AgentsProgestational CompoundsProgestational HormonesProgesterone AgentsProgestinsProgestogelProgestogensProgestolProgestonProgram DevelopmentProlidonProlutonProtocolProtocols documentationPublic HealthQualifyingReadinessRecommendationRecordsRecoveryRegulationRegulatory approvalReportingReproductive HealthResearchRiskRisk FactorsRunningSafetyScienceSelf AdministeredSelf AdministrationServicesSiteStructureSubcutaneous InjectionsSyngesteroneTechnology TransferTherapeutic EstrogenTherapeutic ProgestinTimeTrainingTranslatingUniversitiesUtrogestanWeight GainWeight IncreaseWomanWorkactive followupadiposityat-risk femalesat-risk womenbirth control pillbody weight gainbody weight increasechildbearing ageclinical developmentclinical practice and guidelinesclinical research siteclinical siteclinical testcommercializationconferencecontraceptive efficacyconventioncorpulencedesigndesigningdetermine efficacydevelopmentaldrug candidatedrug/agentefficacy analysisefficacy assessmentefficacy determinationefficacy evaluationefficacy examinationenrollevaluate efficacyexamine efficacyexperiencefemale antifertility drugfemales at high riskfertile agefirst in manfirst-in-humanfollow upfollow-upfollowed upfollowupheavy metal Pbheavy metal leadhigh risk femaleshormonal contraceptionhormonal contraceptiveimprovedinnovateinnovationinnovativeinterestintramuscular drug administrationl-Norgestrelmenmenstrual periodmonthly periodmonthly periodsnext generationnovelopen labelopen label studypersonnelpharmacokinetics and pharmacodynamicspopulation healthpublic-private partnershiprecruitregulatory authorizationregulatory certificationregulatory clearancereproductive agereproductive yearsresearch clinical testingsafety assessmentscreeningscreeningsside effectsubcutaneoussubdermalsubdermal injectionsummitsymposiasymposiumthrombotictraining opportunityvenous thromboembolismwomen at high riskwt gain
Description preview
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) serves as the lead federal agency advancing research in fertility optimization. Within NICHD, the Contraceptive Development Program (CDP) under the Division of Population Health Research (DiPHR) is tasked with developing novel contraceptive methods for both…
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