NCT07346716 Medicines in Breast Milk and Estimated Infant Exposure
| NCT ID | NCT07346716 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Bispebjerg and Frederiksberg |
| Condition | Breastfeeding |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-12-20 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2024-12-20 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Lactating women aged ≥18 years * Current use of one or more prescription or over-the-counter (classified within the ATC system) drugs * Able and willing to provide written informed consent Exclusion Criteria: * Current pregnancy during sample collection * Known and clinically significant pharmacokinetic drug-drug interactions at the time of sampling
Contact & Investigator
Jon Traerup Andersen, Professor, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital
Frequently Asked Questions
Who can join the NCT07346716 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breastfeeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07346716 currently recruiting?
Yes, NCT07346716 is actively recruiting participants. Contact the research team at ditte.resendal.gotfredsen@regionh.dk for enrollment information.
Where is the NCT07346716 trial being conducted?
This trial is being conducted at Copenhagen, Denmark, Copenhagen, Denmark, Herlev, Denmark.
Who is sponsoring the NCT07346716 clinical trial?
NCT07346716 is sponsored by University Hospital Bispebjerg and Frederiksberg. The principal investigator is Jon Traerup Andersen, Professor, MD, PhD at Department of Clinical Pharmacology, Bispbjeg and Frederiksberg Hospital. The trial plans to enroll 250 participants.