List of Clinical Lactation Studies
From the FDA Office of Women's Health
Download Clinical Lactation Study Factsheet PDF (4.24MB)
If you are a study sponsor and would like your study added to the database, please email FDA at Registries@fda.hhs.gov.
Clinical lactation studies are research studies that collect health information from women (and sometimes their babies) who use or receive medical products (such as prescription medicines and vaccines) while breastfeeding (lactating). The information collected can help health care providers and women who are breastfeeding learn more about the safety of medical products used during breastfeeding and may be used to update the medical product's labeling.
FDA does not conduct clinical lactation studies. Studies will be posted on this page on a rolling basis based on a sponsor’s (company that makes the medical product) request to list their study. FDA does not endorse any clinical lactation study and is not responsible for the conduct of clinical lactation studies. This webpage is intended for informational purposes only.
New Knowledge and News on Women's Health (KNOWH) blog post: Understanding Clinical Lactation Studies: What They Are and Why They Matter
| Medicine | Medical Condition | Lactation Study | How to contact (for patients and providers) | Status | Sorting |
|---|---|---|---|---|---|
| BIMZELX® (bimekizumab-bkzx) | Any approved indication | Be Caring Study | Website: https://becaringstudy.com/study/us/en-US/content/homepage Phone: 1-844-599-2273 | Ongoing | |
| Motegrity / Resotran, Prucalopride | Chronic Idiopathic Constipation (CIC) or Functional Constipation | A Breast Milk Study in Lactating Women who Have Been Prescribed Therapeutic Doses of MOTEGRITY® or RESOTRAN® (prucalopride) for Chronic Idiopathic Constipation to Evaluate Prucalopride Concentrations in Breast Milk, and to Collect Incidental Safety Data from the Nursing Infants | Website: https://mommysmilkresearch.org/motegrity/ Phone: 844-605-MILK (6455) | Ongoing | |
| N/A | N/A | Mommy's Milk, The Human Milk Biorepository at UCSD | Website: https://mommysmilkresearch.org/ Phone: 844-605-MILK (6455) | Ongoingopened |