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Phase 3 N=42 Randomized Double-blind Treatment

Dexamethasone for Post Uterine Artery Embolization Pain

Leiomyoma

Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Pain Scores Using the VAS Questionnaire — 0.8; 1.3; 4; 6.1 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Dexamethasone (Drug); Saline (Drug)
Age
Adult · 20+ yrs
Sex
Female
Sponsor
University of Miami
Primary completion
Dec 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Scores Using the VAS Questionnaire
0.8; 1.3; 4; 6.1; 6; 6.3
SECONDARY
Severity of Post-embolization Syndrome Symptoms
0; 0; 0.1; 0.2; 0.3; 0.4
SECONDARY
Change in Symptoms
2.4; 2.3; 1.7; 1.8; 1.9; 1.9
SECONDARY
Change in Quality of Life
5.2; 5.5; 2.5; 1.3

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 of weakness following the procedure.

Eligibility Criteria

Inclusion Criteria

  • Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04655144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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