Uterine HemorrhageNCT04394234
A Study of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants
An observational study of Uterine Hemorrhage, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Hemorrhage
- What is being tested?
- Direct oral anticoagulant (DOACs) and Warfarin
- Type of treatment
- Pill or oral medicine
- How many people
- 961,985 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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]).
- Conditions
- Uterine Hemorrhage
- Being tested
- Direct oral anticoagulant (DOACs), Warfarin
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct oral anticoagulant (DOACs)Drug
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.
WarfarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Direct oral anticoagulant (DOACs) | |
| 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. Receives: Drug: Direct oral anticoagulant (DOACs); Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Severe Uterine Bleed
Number of participants with severe uterine bleed during two time-at-risk periods (on-treatment and all observed time post-index) will be reported.
Measured: From 19-Oct-2010 to 31-Dec-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 May 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine HemorrhageStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 961,985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394234
- Sponsor's protocol ID
- CR108824
- Other IDs
- PCSCVM002566
- Status last verified
- Apr 2025
- First submitted
- 15 May 2020
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Weaver J, Shoaibi A, Truong HQ, Larbi L, Wu S, Wildgoose P, Rao G, Freedman A, Wang L, Yuan Z, Barnathan E. Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA. Drug Saf. 2021 Apr;44(4):479-497. doi: 10.1007/s40264-021-01060-4. Epub 2021 Mar 2.
PubMed 33651368
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across 4 US Observational Databases
- ClinicalTrials.gov ID
- NCT04394234
- Acronym / sponsor ID
- CR108824
- Conditions
- Uterine Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 961,985 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | – | Drug: Direct oral anticoagulant (DOACs)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. |
| Comparator Group | – | Drug: Direct oral anticoagulant (DOACs), Drug: WarfarinParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Comparator Group, Treatment Group |
| WarfarinData 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. | Drug | Comparator Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Derived from this study: PubMed 33651368Weaver J, Shoaibi A, Truong HQ, Larbi L, Wu S, Wildgoose P, Rao G, Freedman A, Wang L, Yuan Z, Barnathan E. Comparative Risk Assessment of Severe Uterine Bleeding Following Exposure to Direct Oral Anticoagulants: A Network Study Across Four Observational Databases in the USA. Drug Saf. 2021 Apr;44(4):479-497. doi: 10.1007/s40264-021-01060-4. Epub 2021 Mar 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Hemorrhage, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Severe Uterine Bleed (time frame: From 19-Oct-2010 to 31-Dec-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04394234, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.