A Phase 3 interventional study of Dexamethasone and Saline in Leiomyoma, sponsored by University of Miami. Completed at 1 site in United States. Open to female participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by University of Miami · Phase 3, Interventional, and Treatment
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.
490 studies on the registry are indexed under Leiomyoma; 81 are open to participants now.
This study's enrollment of 42 is below the median of 62 across 345 interventional studies indexed under Leiomyoma.
Browse Leiomyoma studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria:
A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
Drug: Dexamethasone
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.
Drug: Saline
Dexamethasone delivered to the uterine arterial bed, prior to embolization.
Saline delivered to the uterine arterial bed, prior to embolization.
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).
Time frame: Day 7
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 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.
Time frame: 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: 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-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.
Time frame: 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).
Time frame: Baseline, 3 months
| Milestone | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Started | 21 | 21 |
| Completed | 20 | 20 |
| Not completed | 1 | 1 |
| Withdrew: Consumed thc | 1 | 0 |
| Withdrew: Unilateral embolization | 0 | 1 |
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).
| score on a scale | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Preprocedural | 0.8 ± 1.5 | 1.3 ± 2.1 |
| Immediate | 4 ± 3.2 | 6.1 ± 3.1 |
| 1 Hour | 6 ± 3.3 | 6.3 ± 3.2 |
| 2 Hours | 5.45 ± 2.9 | 5.8 ± 3.1 |
| 3 Hours | 5 ± 2.8 | 4.9 ± 3.2 |
| 6 Hours | 4.6 ± 2.5 | 5.9 ± 3.2 |
| 9 Hours | 4.4 ± 3.0 | 5.9 ± 2.9 |
| 12 Hours | 4.3 ± 3.3 | 4.5 ± 3.2 |
| 24 Hours | 2.5 ± 2.4 | 4.2 ± 2.9 |
| 48 Hours | 2.7 ± 3.2 | 5.1 ± 3.0 |
| 72 Hours | 3.42 ± 2.9 | 4.7 ± 3.0 |
| 96 Hours | 2.35 ± 2.4 | 4.5 ± 3.2 |
| 168 Hours | 1.7 ± 2.6 | 2.9 ± 2.4 |
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.
| score on a scale | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Preprocedural | 0 ± 0 | 0 ± 0 |
| Immediate Postprocedural | 0.1 ± 0.3 | 0.2 ± 0.5 |
| 1 Hour | 0.3 ± 0.8 | 0.4 ± 0.7 |
| 2 Hour | 0.4 ± 0.8 | 0.5 ± 0.8 |
| 3 Hour | 0.4 ± 0.8 | 0.6 ± 1.0 |
| 6 Hour | 0.7 ± 1.0 | 1.1 ± 1.2 |
| 9 Hour | 0.8 ± 1.2 | 1 ± 1.2 |
| 12 Hour | 0.6 ± 0.9 | 0.4 ± 0.6 |
| 24 Hour | 0 ± 0 | 0.2 ± 0.5 |
| 48 Hour | 0.2 ± 0.4 | 0.4 ± 0.7 |
| 72 Hour | 0.3 ± 0.7 | 0.8 ± 1.1 |
| 96 Hour | 0.1 ± 0.4 | 0.4 ± 0.7 |
| 168 Hour | 0.2 ± 0.5 | 0.1 ± 0.2 |
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-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.
| score on a scale | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Bleeding | 2.4 ± 1.5 | 2.3 ± 1.4 |
| Clots | 1.7 ± 1.3 | 1.8 ± 0.91 |
| Fluctuation | 1.9 ± 1.2 | 1.9 ± 1.1 |
| Length | 1.6 ± 1.1 | 1.9 ± 1.1 |
| Pain | 1.8 ± 1.2 | 2.0 ± 1.2 |
| Polyuria | 2.3 ± 1.5 | 2.2 ± 1.5 |
| Nocturia | 2.3 ± 1.6 | 2.1 ± 1.5 |
| Fatigue | 2.5 ± 1.4 | 1.9 ± 1.4 |
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).
| score on a scale | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Baseline | 5.2 ± 1.4 | 5.5 ± 1.0 |
| 3 Month | 2.5 ± 2.0 | 1.3 ± 1.8 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexamethasone Arm | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Saline Arm | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Event | Dexamethasone Arm | Saline Arm |
|---|---|---|
| Groin hematomaSurgical and medical procedures | 1/21 | 1/21 |
| Age, Categorical(Participants) | Dexamethasone Arm | Saline Arm | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 21 | 21 | 42 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Dexamethasone Arm | Saline Arm | Total |
|---|---|---|---|
| Female | 21 | 21 | 42 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Dexamethasone Arm | Saline Arm | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 9 | 16 |
| White | 7 | 4 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 7 | 8 | 15 |
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