A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants

April 25, 2025 updated by: Janssen Research & Development, LLC

Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across 4 US Observational Databases

The purpose of this study is assess the: (a) incidence of severe uterine bleeding (SUB) following exposure to individual direct oral anticoagulant (DOACs) (rivaroxaban, apixaban, dabigatran) and warfarin, (b) individual DOACs (rivaroxaban, apixaban, dabigatran) association with risk of SUB compared with warfarin, and (c) individual DOACs (rivaroxaban, apixaban, dabigatran) associated with risk of SUB compared with other individual DOACs - among women with prior diagnoses for DOAC and warfarin indications (non-valvular atrial fibrillation [NVAF], venous thromboembolism [VTE], total hip replacement [THR] or total knee replacement [TKR]).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

961985

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Titusville, New Jersey, United States, 08560
        • Janssen R&D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study population will include adult women aged 18 years and older who are newly exposed to DOACs or warfarin with greater than or equal to (>=) 183 days of prior continuous database observation between 19-Oct-2010 and 31-Dec-2018 will be assessed for severe uterine bleeding.

Description

Inclusion Criteria:

  • Non-valvular atrial fibrillation (NVAF) diagnosis any time prior and no Venous thromboembolism (VTE) (Deep vein thrombosis [DVT] or Pulmonary embolism [PE]) in the past 183 days and no knee or hip replacement surgery in the past 35 days
  • VTE (DVT or PE) in the past 183 days and no NVAF diagnosis any time prior and no knee or hip replacement surgery in the past 35 days
  • Total hip replacement (THR) or Total knee replacement (TKR) in the past 35 days and no non-valvular atrial fibrillation any time prior and no venous thromboembolism (deep vein thrombosis of pulmonary embolism) in the past 183 days

Exclusion Criteria:

  • Participants were excluded for edoxaban exposure, exposure to other exposures of interest (example: Direct oral anticoagulant [DOACs] for warfarin exposure cohort), hysterectomy, vaginal bleed, and medical, surgical, or transfusion management for vaginal bleeding any time prior to the index exposure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Participants data who are new users of rivaroxaban, apixaban and dabigatran with prior Non-valvular atrial fibrillation/Venous thromboembolism/Total hip replacement (NVAF/VTE/THR) or Total knee replacement (TKR) in a nationally representative population of insured participants in the United States (US) will be compared pairwise.
Drug: Direct oral anticoagulant (DOACs)
Data of participants newly exposed to individual DOACs that is rivaroxaban, apixaban, dabigatran from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
Comparator Group
Participants data who are new users of warfarin, apixaban, and dabigatran with prior NVAF/VTE/THR or TKR in a nationally representative population of insured participants in the US will be compared pairwise.
Drug: Direct oral anticoagulant (DOACs)
Data of participants newly exposed to individual DOACs that is rivaroxaban, apixaban, dabigatran from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
Drug: Warfarin
Data of participants newly exposed to warfarin from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Severe Uterine Bleed
Time Frame: From 19-Oct-2010 to 31-Dec-2018
Number of participants with severe uterine bleed during two time-at-risk periods (on-treatment and all observed time post-index) will be reported.
From 19-Oct-2010 to 31-Dec-2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Investigators

  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2020

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

May 15, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 27, 2025

Last Update Submitted That Met QC Criteria

April 25, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108824
  • PCSCVM002566 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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