Trials / Recruiting
RecruitingNCT06831474
Excretion of Rivaroxaban in Human Breast Milk
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Thomas Jefferson University · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
The aim of our study is to perform a phase 1, single arm clinical trial to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic maternal doses. Our goal is to enhance the limited, although positive, data regarding the safety of rivaroxaban in breastfeeding. Our novel contributions to the existing body of literature will be in our investigation of rivaroxaban at both prophylactic and therapeutic doses, in repeated doses over time, and in a larger sample of participants. These results will provide physicians and national societies with safety data needed to properly counsel patients and advance clinical guidelines for postpartum care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban 10 MG Oral Tablet | 10mg rivaroxaban daily |
| DRUG | Rivaroxaban 20 MG Oral Tablet | 20mg rivaroxaban daily |
Timeline
- Start date
- 2025-07-01
- Primary completion
- 2026-04-01
- Completion
- 2026-07-31
- First posted
- 2025-02-18
- Last updated
- 2025-07-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06831474. Inclusion in this directory is not an endorsement.