Endometriosis, Endometriosis-related Pain
Conditions
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.
Interventions
250 mg oral three times a day for 14 days
DRUGPlacebo
Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported pain persistence | 6 weeks postoperatively. | The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life scores | 1 year postoperatively. | Endometriosis Health Profile-5 on scale of 1-100 with higher scores meaning worse outcome |
| Sexual health | 6 weeks postoperatively. | Female sexual function index on a scale of 0-36 with higher scores meaning higher sexual dysfunction |
| Self-reported pain persistence | 1 year postoperatively. | The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fertility | 6 months postoperatively | Number of pregnancies and miscarriages postoperatively will be compared |
Countries
United States
Outcome results
None listed