Dexamethasone for Post Uterine Artery Embolization Pain

NCT04655144 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 20200788
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Leiomyoma

Keywords

Fibroids; Leiomyoma; post-embolization pain; dexamethasone

Outcome Measures

Primary Outcomes (1)

• 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).

  Day 7

Secondary Outcomes (3)

• Severity of Post-embolization Syndrome Symptoms

  Day 7

• Change in Symptoms

  Baseline, 3 months

• Change in Quality of Life

  Baseline, 3 months

Study Arms (2)

Dexamethasone Arm

EXPERIMENTAL

A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.

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.

Drug: Saline

Interventions

Dexamethasone DRUG

Dexamethasone delivered to the uterine arterial bed, prior to embolization.

Dexamethasone Arm

Saline DRUG

Saline delivered to the uterine arterial bed, prior to embolization.

Saline Arm

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Prasoon Mohan, MD
• Organization: Florida Interventional Institute

contact@flinterventionalinstitute.com

305-204-7276

Study Officials

• Prasoon Mohan, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 7, 2020
• Study Start: January 25, 2021
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: January 7, 2026
• Results First Posted: September 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)