Cimetidine Excretion During Lactation
Trial Summary
Will I have to stop taking my current medications?
Yes, you may need to stop taking certain medications. The trial excludes participants taking medications that interact with cimetidine or affect specific drug transporters. It's best to discuss your current medications with the trial team to see if any need to be stopped.
What data supports the effectiveness of the drug cimetidine when excreted in breast milk?
Research shows that cimetidine is actively transported into breast milk at higher concentrations than expected, but it appears safe for infants as the amount they ingest is small. Additionally, studies in animals indicate that high concentrations of cimetidine in milk do not harm the suckling pups or affect milk composition.12345
Is cimetidine safe for breastfeeding mothers and their infants?
How does the drug cimetidine differ from other treatments for its condition?
What is the purpose of this trial?
This is a prospective, non-randomized, phase I study design evaluating the in vivo activities and expression of OCT1 and BCRP in mammary gland of lactating women at three time points postpartum.
Research Team
Mary Hebert, PharmD, FCCP
Principal Investigator
University of Washington
Eligibility Criteria
This trial is for healthy, lactating or pregnant women planning to breastfeed, aged 18-50, and their nursing infants between 3 weeks to 8 months old. Participants must not be on medications that could interact with the study drug.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of cimetidine 200 mg on each of 3 study days at different postpartum stages
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Drug Excretion in Breast Milk
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator