Dexamethasone for Fibroid

Sylvester Comprehensive Cancer Center, Miami, FL
FibroidDexamethasone - Drug
20 - 50

Study Summary

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

Eligible Conditions
  • Fibroid

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, 3 months

Baseline, 3 months
Change in quality of life
Change in symptoms
Change in uterine fibroid volume
Day 7
Pain scores using the VAS Questionnaire
Severity of post-embolization syndrome symptoms

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Side Effects for

2%Deep Vein Thrombosis
2%Cerebrospinal fluid leak
This histogram enumerates side effects from a completed 2013 Phase 4 trial (NCT01474915) in the Ondansetron ARM group. Side effects include: Fever with 2%, Deep Vein Thrombosis with 2%, Cerebrospinal fluid leak with 2%.

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2 Treatment Groups

Dexamethasone Arm
1 of 2
Saline Arm
1 of 2

Experimental Treatment

Non-Treatment Group

82 Total Participants · 2 Treatment Groups

Primary Treatment: Dexamethasone · Has Placebo Group · Phase 3

Dexamethasone Arm
Experimental Group · 1 Intervention: Dexamethasone · Intervention Types: Drug
Saline Arm
PlaceboComparator Group · 1 Intervention: Saline · Intervention Types: Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 3 months

Who is running the clinical trial?

University of MiamiLead Sponsor
821 Previous Clinical Trials
390,339 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.

Eligibility Criteria

Age 20 - 50 · Female Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women who are eligible for a specific treatment called uterine fibroid embolization for their symptomatic fibroids.

Who else is applying?

What state do they live in?
What site did they apply to?
Sylvester Comprehensive Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

How many patients are you testing this medication on?

"That is correct, the online information hosted on 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.