Health Trials

Excretion of Rivaroxaban in Human Breast Milk

ConditionsPostpartumVTE ProphylaxisVTE (Venous Thromboembolism)RivaroxabanBreastfeedingBreast Milk Collection
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThomas Jefferson University

About this trial

The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.

Eligibility criteria

Qualifiers

Postpartum within 6 weeks of delivery

Greater than 18 years old at expected date of delivery

English speaking

Hemodynamically stable without concern for ongoing blood loss

Disqualifiers

Pregnant

Less than 18 years old at estimated date of delivery

Hemodynamic instability and/or concern for ongoing blood loss

Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period

Trial design

Treatments tested in this trial

  • Rivaroxaban 10 MG Oral Tablet
  • Rivaroxaban 20 MG Oral Tablet

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Thomas Jefferson University

Lead sponsor

Source ClinicalTrials.gov