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

Primary Purpose

Endometriosis, Endometriosis-related Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Metronidazole Oral
Placebo
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometriosis

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Louisville HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Metronidazole

Placebo

Arm Description

Metronidazole

Halal and Kosher certified gelatin placebo capsules

Outcomes

Primary Outcome Measures

Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Secondary Outcome Measures

Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Quality of life scores
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Sexual health
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Self-reported pain persistence
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.

Full Information

First Posted
September 5, 2020
Last Updated
March 1, 2022
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT04554693
Brief Title
The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery
Official Title
The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery: A Prospective, Randomized, Placebo-Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
September 2027 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Endometriosis-related Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metronidazole
Arm Type
Experimental
Arm Description
Metronidazole
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Halal and Kosher certified gelatin placebo capsules
Intervention Type
Drug
Intervention Name(s)
Metronidazole Oral
Intervention Description
250 mg oral three times a day for 14 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days
Primary Outcome Measure Information:
Title
Self-reported pain persistence
Description
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time Frame
6 weeks postoperatively.
Secondary Outcome Measure Information:
Title
Quality of life scores
Description
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time Frame
1 year postoperatively.
Title
Quality of life scores
Description
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time Frame
6 months postoperatively.
Title
Quality of life scores
Description
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time Frame
6 weeks postoperatively.
Title
Quality of life scores
Description
Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome
Time Frame
5 years postoperatively.
Title
Sexual health
Description
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time Frame
6 weeks postoperatively.
Title
Sexual health
Description
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time Frame
6 months postoperatively.
Title
Sexual health
Description
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time Frame
1 year postoperatively.
Title
Sexual health
Description
Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction
Time Frame
5 year postoperatively.
Title
Self-reported pain persistence
Description
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time Frame
1 year postoperatively.
Title
Self-reported pain persistence
Description
The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test.
Time Frame
6 months postoperatively.
Other Pre-specified Outcome Measures:
Title
Fertility
Description
Number of pregnancies and miscarriages postoperatively will be compared
Time Frame
6 months postoperatively
Title
Fertility
Description
Number of pregnancies and miscarriages postoperatively will be compared
Time Frame
1 year postoperatively
Title
Fertility
Description
Number of pregnancies and miscarriages postoperatively will be compared
Time Frame
5 years postoperatively

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female participants
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amira Quevedo, MD
Phone
5025884400
Email
amira.quevedo@uoflhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Resad Pasic, MD, PhD
Phone
5025884400
Email
resad.pasic@louisville.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Resad Pasic, MD, PhD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
AMIRA QUEVEDO, MD
Phone
502-588-4400
Email
amira.quevedo@uoflhealth.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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22819144
Citation
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20567196
Citation
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The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

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