TerminatedPhase 4

The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

Stopped: Principal investigator did not have the necessary staffing resources to continue the study.

United States78 participantsStarted 2020-10-19

Plain-language summary

The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to give informed consent * Women aged 18-50 years old * Scheduled to undergo excision of endometriosis * Able to read and write in English and or Spanish * Pain score \> 2 on a 10 point visual analogue scale at baseline * Negative screening by CAGE questionnaire Exclusion Criteria: * Refusal to surgery * Contraindication to surgery * Known allergy to metronidazole * Known allergy to any component in gelatin placebo capsules * Scheduled hysterectomy * Endometriosis excision surgery within the last 3 months * Elevated serum creatinine * Abnormal liver function test greater than 2 times the normal * Current pregnancy * Breastfeeding * Use of Disulfiram within the last 2 weeks * History of Cockayne syndrome * Inability to abstain from alcohol during the use of study drug

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of Participants With Self Reported Pain Persistence

Timeframe: 6 weeks postoperatively.

Trial details

NCT IDNCT04554693

SponsorUniversity of Louisville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-05

Results submitted2025-03-16

View on ClinicalTrials.gov More Endometriosis trials