What side effects are associated with this type of intervention?

Common treatments for endometriosis, such as oral metronidazole, can cause side effects including gastrointestinal upset, metallic taste, and, less commonly, paresthesias and peripheral neuropathy. Hormonal therapies like estrogen-progestin contraceptives and GnRH agonists/antagonists may lead to menopausal symptoms, decreased bone density, and other hormonal side effects. Dienogest is generally well-tolerated but can cause weight gain, mood changes, and breast tenderness. Levonorgestrel intrauterine devices may reduce dysmenorrhea but have unclear impacts on endometrioma recurrence and can cause irregular bleeding and hormonal side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for endometriosis, primarily focusing on hormonal therapies to reduce inflammation and pain. These include GnRH agonists like leuprolide, which suppress estrogen production, and progestins such as dienogest, which reduce endometrial tissue growth. Additionally, oral contraceptives combining estrogen and progestin are commonly used. While metronidazole itself is not specifically approved for endometriosis, its anti-inflammatory properties are being studied for potential benefits in reducing endometriosis-related symptoms.

What other types of research exist?

Promising alternatives to oral metronidazole for endometriosis treatment include: <ol> <li>Tumor Necrosis Factor-α (TNF-α) inhibitors, which have been shown to reduce embryotoxicity and endometrial cell proliferation.</li> <li></li> </ol> Dienogest, a progestin that suppresses midkine production and has a direct effect on endometriotic cells. 3. Broad-spectrum antibiotics (e.g., vancomycin, neomycin, metronidazole, and ampicillin) that have been shown to reduce endometriotic lesion size and inflammation in experimental studies.

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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

Must not have

History of Cockayne syndrome

Scheduled hysterectomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 year postoperatively.

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial is testing if taking the antibiotic metronidazole can reduce pain after endometriosis surgery in women aged 18-50. The antibiotic works by killing bacteria to prevent infections, which might help with pain relief.

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.

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.

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.

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My pain level is more than 2 out of 10.

Exclusion Criteria

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

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I have a history of Cockayne syndrome.

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I am scheduled for a hysterectomy.

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I have chosen not to undergo surgery.

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I cannot undergo surgery due to health risks.

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

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

Secondary study objectives

Quality of life scores

Self-reported pain persistence

Sexual health

Other study objectives

Fertility

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: 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 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for endometriosis include hormonal therapies, anti-inflammatory medications, and antibiotics like metronidazole. Hormonal therapies, such as estrogen-progestin contraceptives and progestins, suppress ovarian function, leading to the atrophy of endometrial tissue and reduced pain. Anti-inflammatory medications like NSAIDs help alleviate pain by reducing inflammation. Antibiotics like metronidazole disrupt microbial DNA, potentially reducing inflammation and the size of endometriotic lesions. Understanding these mechanisms helps tailor treatments to individual needs, improving symptom management and quality of life for endometriosis patients.

Antibiotic therapy with metronidazole reduces endometriosis disease progression in mice: a potential role for gut microbiota.New drugs in development for the treatment of endometriosis.[What is new about endometriosis?].