NCT04655144: Dex-Fib

Dexamethasone for Post Uterine Artery Embolization Pain

Completed Phase 3 Results posted Last updated 7 January 2026

What this trial tests

Phase 3 trial testing Dexamethasone in Leiomyoma in 42 participants. Completed in 4 December 2024.

Timeline

25 January 2021

Primary endpoint
4 December 2024

4 December 2024

Quick facts

Lead sponsor	University of Miami
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	25 January 2021
Primary completion	4 December 2024
Estimated completion	4 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Dexamethasone (dexamethasone) — full drug profile →
• Saline

Conditions studied

• Leiomyoma — all drugs for Leiomyoma →

Sponsor

University of Miami

Who can join

Adults 20 to 50, female only, with Leiomyoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Scores Using the VAS Questionnaire Primary · 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).

Preprocedural

Group	Value	95% CI
Dexamethasone Arm	0.8	± 1.5
Saline Arm	1.3	± 2.1

Immediate

Group	Value	95% CI
Dexamethasone Arm	4	± 3.2
Saline Arm	6.1	± 3.1

1 Hour

Group	Value	95% CI
Dexamethasone Arm	6	± 3.3
Saline Arm	6.3	± 3.2

2 Hours

Group	Value	95% CI
Dexamethasone Arm	5.45	± 2.9
Saline Arm	5.8	± 3.1

3 Hours

Group	Value	95% CI
Dexamethasone Arm	5	± 2.8
Saline Arm	4.9	± 3.2

6 Hours

Group	Value	95% CI
Dexamethasone Arm	4.6	± 2.5
Saline Arm	5.9	± 3.2

9 Hours

Group	Value	95% CI
Dexamethasone Arm	4.4	± 3.0
Saline Arm	5.9	± 2.9

12 Hours

Group	Value	95% CI
Dexamethasone Arm	4.3	± 3.3
Saline Arm	4.5	± 3.2

Severity of Post-embolization Syndrome Symptoms Secondary · Day 7

Post-Embolization Syndrome (PES) was evaluated using a dedicated PES survey. For nausea and vomiting, severity will be scored as follows: 0 - None 1. \- Mild nausea 2. \- Severe nausea requiring antiemetic medication 3. \- 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.

Preprocedural

Group	Value	95% CI
Dexamethasone Arm	0	± 0
Saline Arm	0	± 0

Immediate Postprocedural

Group	Value	95% CI
Dexamethasone Arm	0.1	± 0.3
Saline Arm	0.2	± 0.5

1 Hour

Group	Value	95% CI
Dexamethasone Arm	0.3	± 0.8
Saline Arm	0.4	± 0.7

2 Hour

Group	Value	95% CI
Dexamethasone Arm	0.4	± 0.8
Saline Arm	0.5	± 0.8

3 Hour

Group	Value	95% CI
Dexamethasone Arm	0.4	± 0.8
Saline Arm	0.6	± 1.0

6 Hour

Group	Value	95% CI
Dexamethasone Arm	0.7	± 1.0
Saline Arm	1.1	± 1.2

9 Hour

Group	Value	95% CI
Dexamethasone Arm	0.8	± 1.2
Saline Arm	1	± 1.2

12 Hour

Group	Value	95% CI
Dexamethasone Arm	0.6	± 0.9
Saline Arm	0.4	± 0.6

Change in Symptoms Secondary · Baseline, 3 months

The Fibroid Symptom Score was assessed using the Uterine Fibroid Embolization (UFE) Quality of Life and Symptomatology Survey. This survey evaluates eight symptoms: 1. Degree of bleeding 2. Presence of clots 3. Variation in the duration of periods 4. Variation in the length of periods 5. Pelvic pain or pressure 6. Frequency of daytime urination 7. Frequency of nighttime urination 8. 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-proc

Bleeding

Group	Value	95% CI
Dexamethasone Arm	2.4	± 1.5
Saline Arm	2.3	± 1.4

Clots

Group	Value	95% CI
Dexamethasone Arm	1.7	± 1.3
Saline Arm	1.8	± 0.91

Fluctuation

Group	Value	95% CI
Dexamethasone Arm	1.9	± 1.2
Saline Arm	1.9	± 1.1

Length

Group	Value	95% CI
Dexamethasone Arm	1.6	± 1.1
Saline Arm	1.9	± 1.1

Pain

Group	Value	95% CI
Dexamethasone Arm	1.8	± 1.2
Saline Arm	2.0	± 1.2

Polyuria

Group	Value	95% CI
Dexamethasone Arm	2.3	± 1.5
Saline Arm	2.2	± 1.5

Nocturia

Group	Value	95% CI
Dexamethasone Arm	2.3	± 1.6
Saline Arm	2.1	± 1.5

Fatigue

Group	Value	95% CI
Dexamethasone Arm	2.5	± 1.4
Saline Arm	1.9	± 1.4

Change in Quality of Life Secondary · Baseline, 3 months

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).

Baseline

Group	Value	95% CI
Dexamethasone Arm	5.2	± 1.4
Saline Arm	5.5	± 1.0

3 Month

Group	Value	95% CI
Dexamethasone Arm	2.5	± 2.0
Saline Arm	1.3	± 1.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dexamethasone Arm

Serious: 0/21 (0%)

Deaths: 0/21

Saline Arm

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (1 terms — click to expand)

Reaction	System	Dexamethasone Arm	Saline Arm
Groin hematoma	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT04655144 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.