LeiomyomaPhase 3Dex-FibNCT04655144
Dexamethasone for Post Uterine Artery Embolization Pain
A Phase 3 study testing Dexamethasone and Saline in people with Leiomyoma, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Dexamethasone and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 4 Dec 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
Who cannot join
- Currently pregnant or actively attempting to conceive
- Those deemed mentally impaired to make their own medical decisions
- Previous documented allergy to dexamethasone
- Those currently taking daily steroids for any reason
- Those with diabetes or deemed to be pre-diabetic
- Those with contraindications for angiography
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
About this study
Official title: Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
The purpose of this research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.
- Conditions
- Leiomyoma
- Being tested
- Dexamethasone, Saline
- Keywords
- Fibroids, Leiomyoma, post-embolization pain, dexamethasone
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
SalineDrug
Saline delivered to the uterine arterial bed, prior to embolization.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Arm | Experimental | A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. Receives: Drug: Dexamethasone |
| Saline Arm | Placebo comparator | A volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores Using the VAS Questionnaire
Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).
Measured: Day 7
Secondary outcomes (3)
Severity of Post-embolization Syndrome Symptoms
Post-Embolization Syndrome (PES) was evaluated using a dedicated PES survey.
For nausea and vomiting, severity will be scored as follows:
0 - None
- - Mild nausea
- - Severe nausea requiring antiemetic medication
- - Vomiting A score of 0 represents no symptoms (least severe), while a score of 3 represents the most severe symptoms. The scoring range is 0 to 3.
Measured: Day 7
Change in Symptoms
The Fibroid Symptom Score was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey. This survey evaluates eight symptoms:
- Degree of bleeding
- Presence of clots
- Variation in the duration of periods
- Variation in the length of periods
- Pelvic pain or pressure
- Frequency of daytime urination
- Frequency of nighttime urination
- Fatigue
Each symptom is scored from 1 to 5, with higher scores indicating more severe symptoms.
The table below presents the mean change in score for each symptom after the intervention, compared to the pre-procedure score. Higher positive numbers indicate greater symptom improvement. In this table, the maximum possible change for an individual symptom is +4, and the minimum is -4.
Measured: Baseline, 3 months
Change in Quality of Life
Change in participant quality of life was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey with a total subsection score ranging from 0-6 with the highest score indicating the worst quality of life from fibroid symptoms and vice versa (6=Terrible and 0=Delighted).
Measured: Baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start25 Jan 2021
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prasoon Mohan, University of Miami
- Investigators
- Prasoon Mohan, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655144
- Sponsor's protocol ID
- 20200788
- Acronym
- Dex-Fib
- Status last verified
- Aug 2025
- First submitted
- 2 Dec 2020
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Briley K Jr, Reddy R, Cavada A, Alessandrino F, Zarnegarnia Y, Carugno J, Miller Z, Venkat S, Allakhverdieva EA, Mohan P. Intraarterial Dexamethasone for Pain Relief After Uterine Fibroid Embolization: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2625004. doi: 10.1001/jamanetworkopen.2026.25004.
PubMed 42507444
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-Arterial Dexamethasone for the Alleviation of Pain and Postembolization Syndrome Following Uterine Artery Embolization
- ClinicalTrials.gov ID
- NCT04655144
- Acronym / sponsor ID
- Dex-Fib / 20200788
- Conditions
- Leiomyoma
- Keywords
- Fibroids, Leiomyoma, post-embolization pain, dexamethasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Posted 12 Sep 2025
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 research is to investigate if administration steroids (anti-inflammatory medication) via the uterine arteries during uterine fibroid embolization (A non surgical procedure for treating uterine fibroids by blocking their blood supply) can help reduce the pain, nausea, vomiting, and general feeling of weakness following the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Arm | Experimental | Drug: DexamethasoneA total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization. |
| Saline Arm | Placebo comparator | Drug: SalineA volume of normal saline, equal to the total volume delivered in the Dexamethasone Arm, will be administered into each uterine artery prior to uterine artery embolization. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
Key exclusion criteria (7 listed)
- Currently pregnant or actively attempting to conceive
- Those deemed mentally impaired to make their own medical decisions
- Previous documented allergy to dexamethasone
- Those currently taking daily steroids for any reason
- Those with diabetes or deemed to be pre-diabetic
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 |
|---|---|---|
| DexamethasoneDexamethasone delivered to the uterine arterial bed, prior to embolization. | Drug | Dexamethasone Arm |
| SalineSaline delivered to the uterine arterial bed, prior to embolization. | Drug | Saline Arm |
Primary outcome
Pain Scores Using the VAS Questionnaire
Time frame: Day 7
Pain is measured using a modified Visual Analogue Score (VAS), which has a total score ranging from 0 (no pain at all) to 10 (worst pain).
3 secondary outcomes
Severity of Post-embolization Syndrome Symptoms
Time frame: Day 7
Change in Symptoms
Time frame: Baseline, 3 months
Change in Quality of Life
Time frame: Baseline, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42507444Briley K Jr, Reddy R, Cavada A, Alessandrino F, Zarnegarnia Y, Carugno J, Miller Z, Venkat S, Allakhverdieva EA, Mohan P. Intraarterial Dexamethasone for Pain Relief After Uterine Fibroid Embolization: A Randomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2625004. doi: 10.1001/jamanetworkopen.2026.25004.
- Individual participant dataSharing planned: No
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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.
Prasoon Mohan, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone and Saline in people with Leiomyoma, run by University of Miami 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 1 inclusion and 7 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 7 Jan 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pain Scores Using the VAS Questionnaire (time frame: Day 7). 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 NCT04655144, 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 7 Jan 2026; AzTrials last refreshed its copy on 31 Oct 2026.