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Principal investigator did not have the necessary staffing resources to continue the study.
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The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Experimental | Metronidazole |
|
| Placebo | Placebo Comparator | Halal and Kosher certified gelatin placebo capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole Oral | Drug | 250 mg oral three times a day for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Via Endometriosis Health Profile-5 | Endometriosis Health Profile-5 on scale of 0-100, with higher scores meaning worse outcome, using continuous variables reported as means. | 6 weeks postoperatively. |
| Sexual Health Via Female Sexual Function Index |
| Measure | Description | Time Frame |
|---|---|---|
| Fertility | Number of pregnancies and miscarriages postoperatively will be compared | 1 year postoperatively |
| Fertility | Number of pregnancies and miscarriages postoperatively will be compared |
Inclusion Criteria:
Exclusion Criteria:
Female participants
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| Name | Affiliation | Role |
|---|---|---|
| Resad Pasic, MD, PhD | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22819144 | Background | 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. | |
| 31486802 | Background | 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. |
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Excluded=64
Declined to participate=36
Did not meet inclusion criteria=28
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole | Participants took metronidazole 250 mg oral three times a day for 14 days after surgery. |
| FG001 | Placebo | Participants took Halal and Kosher certified gelatin placebo capsules orally three times a day for 14 days after surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole | Participants took metronidazole 250 mg oral three times a day for 14 days after surgery. |
| BG001 | Placebo | Participants took Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days after surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Age 18-50 years old |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With 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. | Posted | Number | Percentage with persistence of pain | 6 weeks postoperatively. |
|
baseline through 6 weeks post-op.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metronidazole | Metronidazole Metronidazole Oral: 250 mg oral three times a day for 14 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clavien-Dindo Grade One | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Resad Pasic | University of Louisville | 502-561-7465 | r0pasi01@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: study protocol and statistical analysis plan | Oct 16, 2020 | Apr 21, 2026 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Placebo |
| Drug |
Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days |
|
Female sexual function index on a scale of 2-36 with higher scores meaning higher sexual dysfunction |
| 6 weeks postoperatively. |
| Percentage of Participants With 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 months postoperatively. |
| Percentage of Participants With 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. | 1 year postoperatively. |
| 5 years postoperatively |
| 20567196 | Background | Practice bulletin no. 114: management of endometriosis. Obstet Gynecol. 2010 Jul;116(1):223-236. doi: 10.1097/AOG.0b013e3181e8b073. No abstract available. |
| 15482763 | Background | 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. |
| 7926075 | Background | 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. |
| 31827467 | Background | 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. |
| 31454452 | Background | 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. |
| 31037294 | Background | 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. |
| 17584822 | Background | 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. |
| 31623187 | Background | 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. |
| 30069974 | Background | 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. |
| 26662472 | Background | 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. |
| 31551115 | Background | 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. |
| 30809655 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Sex/Gender female participants only | no male participants due to prevalence of disease in female only population | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Participant counts of white vs. nonwhite race | Count of Participants | Participants |
|
| Region of Enrollment | Enrollment took place at the University of Louisville Hospital, Louisville, Kentucky, USA. | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Quality of Life Via Endometriosis Health Profile-5 | Endometriosis Health Profile-5 on scale of 0-100, with higher scores meaning worse outcome, using continuous variables reported as means. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postoperatively. |
|
|
|
| Secondary | Sexual Health Via Female Sexual Function Index | Female sexual function index on a scale of 2-36 with higher scores meaning higher sexual dysfunction | Posted | Mean | Full Range | score on a scale of 2-36 | 6 weeks postoperatively. |
|
|
|
| Secondary | Percentage of Participants With 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. | This outcome measure data was not collected as study was terminated. We collected 6 weeks of postoperative data. This data is reported is reported in the table for primary outcome measure #1. | Posted | 6 months postoperatively. |
|
|
| Secondary | Percentage of Participants With 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. | This outcome measure data was not collected as study was terminated. We collected 6 weeks of postoperative data. This data is reported is reported in the table for primary outcome measure #1. | Posted | 1 year postoperatively. |
|
|
| Other Pre-specified | Fertility | Number of pregnancies and miscarriages postoperatively will be compared | This outcome measure data was not collected since only the primary outcome at the 6-week post op timepoint was collected and analyzed . | Posted | 1 year postoperatively |
|
|
| Other Pre-specified | Fertility | Number of pregnancies and miscarriages postoperatively will be compared | This outcome measure data was not collected since only the primary outcome at the 6-week post op timepoint was collected and analyzed . | Posted | 5 years postoperatively |
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 3 |
| 38 |
| EG001 | Placebo | Halal and Kosher certified gelatin placebo capsules Placebo: Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days | 0 | 34 | 0 | 34 | 4 | 34 |
| Clavien-Dindo Grade two | Surgical and medical procedures | Systematic Assessment |
|
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| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |