NCT04554693

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
16mo left

Started Oct 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress81%
Oct 2020Sep 2027

First Submitted

Initial submission to the registry

September 5, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 19, 2020

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

6.9 years

First QC Date

September 5, 2020

Last Update Submit

January 22, 2025

Conditions

EndometriosisEndometriosis-related Pain

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks postoperatively.

Secondary Outcomes (10)

  • Quality of life scores

    1 year postoperatively.

  • Quality of life scores

    6 months postoperatively.

  • Quality of life scores

    6 weeks postoperatively.

  • Quality of life scores

    5 years postoperatively.

  • Sexual health

    6 weeks postoperatively.

  • +5 more secondary outcomes

Other Outcomes (3)

  • Fertility

    6 months postoperatively

  • Fertility

    1 year postoperatively

  • Fertility

    5 years postoperatively

Study Arms (2)

Metronidazole

EXPERIMENTAL

Metronidazole

Drug: Metronidazole Oral

Placebo

PLACEBO COMPARATOR

Halal and Kosher certified gelatin placebo capsules

Drug: Placebo

Interventions

Metronidazole OralDRUG

250 mg oral three times a day for 14 days

Metronidazole
PlaceboDRUG

Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale participants
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

Related Publications (14)

  • Burney RO, Giudice LC. Pathogenesis and pathophysiology of endometriosis. Fertil Steril. 2012 Sep;98(3):511-9. doi: 10.1016/j.fertnstert.2012.06.029. Epub 2012 Jul 20.

    PMID: 22819144BACKGROUND

  • Working group of ESGE, ESHRE and WES; Saridogan E, Becker CM, Feki A, Grimbizis GF, Hummelshoj L, Keckstein J, Nisolle M, Tanos V, Ulrich UA, Vermeulen N, De Wilde RL. Recommendations for the Surgical Treatment of Endometriosis. Part 1: Ovarian Endometrioma. Hum Reprod Open. 2017 Dec 19;2017(4):hox016. doi: 10.1093/hropen/hox016. eCollection 2017.

    PMID: 31486802BACKGROUND

  • Practice bulletin no. 114: management of endometriosis. Obstet Gynecol. 2010 Jul;116(1):223-236. doi: 10.1097/AOG.0b013e3181e8b073. No abstract available.

    PMID: 20567196BACKGROUND

  • Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84. doi: 10.1016/j.fertnstert.2004.03.046.

    PMID: 15482763BACKGROUND

  • Sutton CJ, Ewen SP, Whitelaw N, Haines P. Prospective, randomized, double-blind, controlled trial of laser laparoscopy in the treatment of pelvic pain associated with minimal, mild, and moderate endometriosis. Fertil Steril. 1994 Oct;62(4):696-700. doi: 10.1016/s0015-0282(16)56990-8.

    PMID: 7926075BACKGROUND

  • Quaranta G, Sanguinetti M, Masucci L. Fecal Microbiota Transplantation: A Potential Tool for Treatment of Human Female Reproductive Tract Diseases. Front Immunol. 2019 Nov 26;10:2653. doi: 10.3389/fimmu.2019.02653. eCollection 2019.

    PMID: 31827467BACKGROUND

  • Leonardi M, Hicks C, El-Assaad F, El-Omar E, Condous G. Endometriosis and the microbiome: a systematic review. BJOG. 2020 Jan;127(2):239-249. doi: 10.1111/1471-0528.15916. Epub 2019 Sep 19.

    PMID: 31454452BACKGROUND

  • Chadchan SB, Cheng M, Parnell LA, Yin Y, Schriefer A, Mysorekar IU, Kommagani R. Antibiotic therapy with metronidazole reduces endometriosis disease progression in mice: a potential role for gut microbiota. Hum Reprod. 2019 Jun 4;34(6):1106-1116. doi: 10.1093/humrep/dez041.

    PMID: 31037294BACKGROUND

  • Simoens S, Hummelshoj L, D'Hooghe T. Endometriosis: cost estimates and methodological perspective. Hum Reprod Update. 2007 Jul-Aug;13(4):395-404. doi: 10.1093/humupd/dmm010.

    PMID: 17584822BACKGROUND

  • Nogueira F, Sharghi S, Kuchler K, Lion T. Pathogenetic Impact of Bacterial-Fungal Interactions. Microorganisms. 2019 Oct 16;7(10):459. doi: 10.3390/microorganisms7100459.

    PMID: 31623187BACKGROUND

  • Mert I, Walther-Antonio M, Mariani A. Case for a role of the microbiome in gynecologic cancers: Clinician's perspective. J Obstet Gynaecol Res. 2018 Sep;44(9):1693-1704. doi: 10.1111/jog.13701. Epub 2018 Aug 2.

    PMID: 30069974BACKGROUND

  • Moloney RD, Johnson AC, O'Mahony SM, Dinan TG, Greenwood-Van Meerveld B, Cryan JF. Stress and the Microbiota-Gut-Brain Axis in Visceral Pain: Relevance to Irritable Bowel Syndrome. CNS Neurosci Ther. 2016 Feb;22(2):102-17. doi: 10.1111/cns.12490. Epub 2015 Dec 10.

    PMID: 26662472BACKGROUND

  • Guo R, Chen LH, Xing C, Liu T. Pain regulation by gut microbiota: molecular mechanisms and therapeutic potential. Br J Anaesth. 2019 Nov;123(5):637-654. doi: 10.1016/j.bja.2019.07.026. Epub 2019 Sep 21.

    PMID: 31551115BACKGROUND

  • Glick LR, Sossenheimer PH, Ollech JE, Cohen RD, Hyman NH, Hurst RD, Rubin DT. Low-Dose Metronidazole is Associated With a Decreased Rate of Endoscopic Recurrence of Crohn's Disease After Ileal Resection: A Retrospective Cohort Study. J Crohns Colitis. 2019 Sep 19;13(9):1158-1162. doi: 10.1093/ecco-jcc/jjz047.

    PMID: 30809655BACKGROUND

MeSH Terms

Conditions

Endometriosis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Resad Pasic, MD, PhD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Fellowship in Advanced Gynecologic Endoscopy, Department of Obstetrics and Gynecology and Woman's Health, University of Louisville School of Medicine

Study Record Dates

First Submitted

September 5, 2020

First Posted

September 18, 2020

Study Start

October 19, 2020

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

January 27, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)