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Dexamethasone for Post-Embolization Pain in Fibroids (Dex-Fib Trial)

Phase 3
Waitlist Available
Led By Prasoon Mohan, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
Women who meet criteria to undergo uterine fibroid embolization for symptomatic fibroids.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights

Dex-Fib Trial Summary

This trial is investigating whether giving steroids through the uterine arteries during fibroid embolization can help reduce pain, nausea, vomiting, and weakness afterwards.

Who is the study for?
This trial is for women who are eligible for uterine fibroid embolization to treat painful and symptomatic fibroids. It's not open to those on daily steroids, with angiography issues, pregnant or trying to conceive, allergic to dexamethasone, diabetic/pre-diabetic, prisoners, or mentally impaired.Check my eligibility
What is being tested?
The study tests if injecting the steroid dexamethasone directly into the uterine arteries during a non-surgical procedure can reduce post-procedure pain and discomfort compared to saline (a placebo).See study design
What are the potential side effects?
Dexamethasone may cause side effects such as increased blood sugar levels, possible infection risk increase due to immune system suppression, mood swings, weight gain and insomnia.

Dex-Fib Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for a procedure to treat my painful fibroids.
Select...
I am eligible for a procedure to treat my painful fibroids.

Dex-Fib Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain scores using the VAS Questionnaire
Secondary outcome measures
Change in quality of life
Change in symptoms
Change in uterine fibroid volume
+1 more

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

Dex-Fib Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Dexamethasone ArmExperimental Treatment1 Intervention
A total of 5mg dexamethasone will be administered into each uterine artery (10mg total) prior to uterine artery embolization.
Group II: Saline ArmPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
897 Previous Clinical Trials
409,178 Total Patients Enrolled
Prasoon Mohan, MD5.02 ReviewsPrincipal Investigator - University of Miami
University of Miami
1 Previous Clinical Trials
5Patient Review
They were very understanding and had a lot of information.

Media Library

Dexamethasone Clinical Trial Eligibility Overview. Trial Name: NCT04655144 — Phase 3
Fibroid Research Study Groups: Saline Arm, Dexamethasone Arm
Fibroid Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT04655144 — Phase 3
Dexamethasone 2023 Treatment Timeline for Medical Study. Trial Name: NCT04655144 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the medical requirements to participate in this trial?

"The team conducting this clinical trial is looking for 82 individuals, all between the ages of 20 and 50, who currently have leiomyoma. Furthermore, it is imperative that potential participants also fit the following description: women who would be good candidates for uterine fibroid embolization due to their symptomatic fibroids."

Answered by AI

To what purpose is Dexamethasone most often administered?

"Dexamethasone is frequently used to treat ophthalmia and sympathetic. Other potential conditions that this medication can help manage include branch retinal vein occlusion and macular edema."

Answered by AI

Is this research only open to seniors, or will younger patients be able to enroll as well?

"The focus of this research is to recruit individuals who are between 20-50 years old."

Answered by AI

How many patients are you testing this medication on?

"That is correct, the online information hosted on clinicaltrials.gov specifies that this trial is open for recruitment. It was originally posted on 1/25/2021, with the most recent update being on 3/10/2022. The trial has 82 spots open for participants at 1 location."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Sylvester Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
~14 spots leftby Dec 2024