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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.

Be between 18 and 65 years old

Must not have

Those with diabetes or deemed to be pre-diabetic

Those deemed mentally impaired to make their own medical decisions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 3 months

Awards & highlights

Pivotal 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.

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).

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am eligible for a procedure to treat my painful fibroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have diabetes or am considered pre-diabetic.

Select...

I am able to make my own medical decisions.

Select...

I am currently taking daily steroids for a condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 3 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain scores using the VAS Questionnaire

Secondary study objectives

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

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

~2650

0 / 4Eligibility criteria met