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Drug Excretion in Breast Milk

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Eligibility criteria shortened, about 11 wordsv4 See this version in full on ClinicalTrials.gov ↗
  2. Minor Start date changed from estimate of Jan 15, 2024 to Dec 4, 2023v3
  3. Notable Start date: Oct 1, 2023 to Jan 15, 2024v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06056583
Lead Sponsor University of Washington
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions Postpartum, Lactation, Drugs in Breast Milk, Mammary Drug Transporters, BCRP, OCT1
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov