[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619599":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":24,"locations":32,"responsibleParty":61,"collaborators":10,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":10,"studyType":78,"phases":10,"briefSummary":79,"conditions":80,"keywords":86,"overallStatus":35,"whyStopped":10,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"University Hospital Bispebjerg and Frederiksberg","OTHER",[8],{"label":9,"type":10,"description":10,"interventionNames":11},"Breastfeeding women on medication",null,[12],"Drug: Prescription Drugs",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":10},"DRUG","Prescription Drugs","Exposure to prescription medicines taken by breastfeeding women during routine treatment. The study does not assign medications but observes drug transfer into human milk from exposures occurring as part of usual care.",[9],[20],{"name":21,"affiliation":22,"role":23},"Jon Traerup Andersen, Professor, MD, PhD","Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Ditte Resendal Gotfredsen, MD","CONTACT","+4521472051","ditte.resendal.gotfredsen@regionh.dk",{"name":21,"role":27,"phone":10,"phoneExt":10,"email":31},"jon.thor.traerup.andersen@regionh.dk",[33,48,53],{"facility":34,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Clinical Pharmacology","RECRUITING","Copenhagen","Denmark","DK",{"type":40,"coordinates":41},"Point",[42,43],12.56553,55.67594,{"lat":43,"lon":42},[46,47],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},{"name":21,"role":27,"phone":10,"phoneExt":10,"email":31},{"facility":49,"status":35,"city":36,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":50,"geoPoint":52,"contacts":10},"Mental health services, Capital Region of Denmark",{"type":40,"coordinates":51},[42,43],{"lat":43,"lon":42},{"facility":54,"status":35,"city":55,"state":10,"zip":10,"country":37,"countryCode":38,"cosmosGeoPoint":56,"geoPoint":60,"contacts":10},"Department of Obstetrics and Gynecology, Herlev Hospital","Herlev",{"type":40,"coordinates":57},[58,59],12.43998,55.72366,{"lat":59,"lon":58},{"type":23,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Jón Þór Trærup Andersen","Professor, PhD,","100619599","medicines-in-breast-milk-and-estimated-infant-exposure-100619599",false,"NCT07346716","Medicines in Breast Milk and Estimated Infant Exposure","Medication Concentrations in Human Milk (MedMilk) and Potential Adverse Effects in Breastfed Infants: an Exploratory Clinical Study","MedMilk","Inclusion Criteria:\n\n* Lactating women aged ≥18 years\n* Current use of one or more prescription or over-the-counter (classified within the ATC system) drugs\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Current pregnancy during sample collection\n* Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling",true,"FEMALE","18 Years",{"count":76,"type":77},250,"ESTIMATED","OBSERVATIONAL","The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child. The study includes breastfeeding women who are already using prescription or over-the-counter medicines as part of their usual care. Participants provide samples of breast milk and urine and complete a questionnaire about maternal and infant health. The collected data will be used to quantify medicine concentrations in milk and estimate the relative infant dose. The study aims to contribute new data to support safer prescribing and more informed counselling during breastfeeding",[81,82,83,84,85],"Breastfeeding","Medication Safety","Lactation","Drug Exposure Via Breast Milk","Pharmacokinetic Parameters",[87,88,89,90],"breastfeeding","lactation","drug transfer into breast milk","medication safety","2026-01-07",{"date":93,"type":94},"2026-01-16","ACTUAL",{"date":96,"type":94},"2024-12-20",{"date":98,"type":77},"2030-01",{"name":5,"class":6},3]