Actively Recruiting
Medicines in Breast Milk and Estimated Infant Exposure
Led by University Hospital Bispebjerg and Frederiksberg · Updated on 2026-01-16
250
Participants Needed
3
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Medicines in Breast Milk and Estimated Infant Exposure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Lactating women aged 618 years
- Current use of one or more prescription or over-the-counter drugs classified within the ATC system
- Able and willing to provide written informed consent
You will not qualify if you...
- Current pregnancy during sample collection
- Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Department of Clinical Pharmacology
Copenhagen, Denmark
Actively Recruiting
2
Mental health services, Capital Region of Denmark
Copenhagen, Denmark
Actively Recruiting
3
Department of Obstetrics and Gynecology, Herlev Hospital
Herlev, Denmark
Actively Recruiting
Research Team
D
Ditte Resendal Gotfredsen, MD
CONTACT
J
Jon Traerup Andersen, Professor, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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