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Medicines in Breast Milk and Estimated Infant Exposure

NCT07346716 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 250

Last updated 2026-01-16

No results posted yet for this study

Summary

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

Conditions

  • Breastfeeding
  • Medication Safety
  • Lactation
  • Drug Exposure Via Breast Milk
  • Pharmacokinetic Parameters

Interventions

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.

Sponsors & Collaborators

  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Principal Investigators

  • Jon Traerup Andersen, Professor, MD, PhD · Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-20
Primary Completion
2028-01-31
Completion
2030-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07346716 on ClinicalTrials.gov