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Anti-infective Agent

Metronidazole for Postoperative Pain in Endometriosis

Phase 4

Recruiting

Led By Resad Pasic, MD, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women aged 18-50 years old

Pain score > 2 on a 10 point visual analogue scale at baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year postoperatively.

Awards & highlights

Study Summary

This trial is testing if the antibiotic metronidazole can reduce post-surgery pain for endometriosis patients.

Who is the study for?

This trial is for women aged 18-50 who can consent, read and write in English or Spanish, have a pain score over 2 due to endometriosis, and are scheduled for excision surgery. It's not for those pregnant, breastfeeding, allergic to metronidazole, with recent endometriosis surgery or certain health issues like abnormal liver tests.Check my eligibility

What is being tested?

The study aims to see if low dose oral Metronidazole reduces postoperative pain after endometriosis surgery compared to a placebo. Participants will report their pain levels after receiving either the medication or a placebo.See study design

What are the potential side effects?

Metronidazole may cause side effects such as digestive upset (nausea, vomiting), metallic taste in mouth, dizziness and rash. Alcohol must be avoided as it can lead to severe nausea and vomiting when combined with Metronidazole.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman aged between 18 and 50.

Select...

My pain level is more than 2 out of 10.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Quality of life scores

Self-reported pain persistence

Sexual health

Other outcome measures

Fertility

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: MetronidazoleExperimental Treatment1 Intervention

Metronidazole

Group II: PlaceboPlacebo Group1 Intervention

Halal and Kosher certified gelatin placebo capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metronidazole Oral

2019

Completed Phase 4

~190

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

339 Previous Clinical Trials

76,590 Total Patients Enrolled

Resad Pasic, MD, PhDPrincipal Investigator - University of Louisville

University Of Louisville Research Foundation

University Of Louisville School Of Medicine (Medical School)

1 Previous Clinical Trials

142 Total Patients Enrolled

Media Library

Metronidazole Oral (Anti-infective Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04554693 — Phase 4

Endometriosis Research Study Groups: Metronidazole, Placebo

Endometriosis Clinical Trial 2023: Metronidazole Oral Highlights & Side Effects. Trial Name: NCT04554693 — Phase 4

Metronidazole Oral (Anti-infective Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04554693 — Phase 4

Endometriosis Patient Testimony for trial: Trial Name: NCT04554693 — Phase 4

Frequently Asked Questions

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

What is the total number of volunteers enlisted in this experiment?

"Affirmative. According to the details on clinicaltrials.gov, recruitment for this medical study is ongoing since it was first posted in October of 2020 and last updated in March of 2022. 90 patients are required at a single centre."

Answered by AI

Are there still openings available in this clinical research?

"Per the clinicaltrials.gov portal, this research is actively recruiting as of March 1st 2022 and was initially proposed on October 19th 2020."

Answered by AI

Is Metronidazole Oral consumption deemed safe by medical professionals?

"There is data from multiple clinical trials attesting to Metronidazole Oral's safety, so it earned a score of 3 on our 1-3 scale."

Answered by AI

Is this research program open to elderly individuals over the age of eighty?

"This clinical trial requires that qualified applicants have to be between 18 and 50 years of age. Alternatively, 80 studies are available for those under 18 while 417 are focused on individuals over 65."

Answered by AI

What medical conditions does Metronidazole Oral typically target?

"Metronidazole Oral is a commonly used treatment for bacterial infections, but it also can be useful for managing entamoeba histolytica, bacterial septicemia and vaginitis."

Answered by AI

What type of participant is best suited for this medical investigation?

"We are looking for 90 women aged 18-50 with endometrioma who have a baseline pain score higher than 2 on the 10 point visual analog scale and pass negative screenings from CAGE questionnaires."

Answered by AI

Who else is applying?

What state do they live in?

Texas

What site did they apply to?

University of Louisville Hospital

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I was diagnosed with stage IV endometriosis August 4th via laparoscopy. I was in debilitating pain for 8 years. I tried valium, mataxalone, meloxicam, naproxen sodium, tylenol, ibuprofen, tens units, and other methods. Nothing was enough relief from my pain to function.

PatientReceived 1 prior treatment