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Terminated
NCT04554693
The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery
Conditions: Endometriosis, Endometriosis-related Pain
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 78
Sponsor: University of Louisville
Location: University of Louisville Hospital Louisville Kentucky
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.
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
Source: ClinicalTrials.gov (NCT04554693). StuddyBuddy aggregates publicly available trial information.