Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting now

Conditions studied: Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI

In brief

Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.

Key facts

Study ID

NCT03511118

Run by

Duke University

People needed

1600

Starts

2018-10-04

Expected to finish

2028-07-31

Last updated by the study team

2026-07-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.
• Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.

You may not qualify if…

• Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.
• Known pregnancy during PK sampling.

Where it is running

• Texas Tech University Health Sciences Center School of Medicine. — Amarillo, Texas, United States (enrolling)
• University of Texas Medical Branch - Galveston — Galveston, Texas, United States (enrolling)
• University of Texas Health Science Center at Houston — Houston, Texas, United States (enrolling)
• The Women's Hospital of Texas — Houston, Texas, United States (enrolling)
• University of Texas Health Science Center — San Antonio, Texas, United States (enrolling)
• University of Utah — Salt Lake City, Utah, United States (enrolling)
• Loma Linda University Health — Loma Linda, California, United States (enrolling)
• Ann and Robert H. Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• University of California-San Diego Medical Center — La Jolla, California, United States (enrolling)
• Duke University Maternal and Fetal Medicine — Durham, North Carolina, United States (enrolling)
• Oregon Health & Science University — Portland, Oregon, United States (enrolling)
• Children's Hospital and Clinics - Minneapolis — Minneapolis, Minnesota, United States (enrolling)
• University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States (enrolling)
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
• Northwestern University — Chicago, Illinois, United States
• Indiana University Health — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of New Mexico, Health Sciences Center — Albuquerque, New Mexico, United States
• University of North Carolina Hospital — Chapel Hill, North Carolina, United States
• Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine — Philadelphia, Pennsylvania, United States
• University of Washington — Seattle, Washington, United States
• Lawson Health Research Institute — London, Ontario, Canada

Full record on ClinicalTrials.gov

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