NCT04554693

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

The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: a Prospective, Randomized, Placebo-Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study. Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days. Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.

Conditions

• Endometriosis
• Endometriosis-related Pain

Interventions

Type	Name	Description
DRUG	Metronidazole Oral	250 mg oral three times a day for 14 days
DRUG	Placebo	Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days

Timeline

• Start date: 2020-10-19
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2020-09-18
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study