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 |
|---|---|---|
| Percentage of Participants With 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 Via Endometriosis Health Profile-5 | 6 weeks postoperatively. | Endometriosis Health Profile-5 on scale of 0-100, with higher scores meaning worse outcome, using continuous variables reported as means. |
| Sexual Health Via Female Sexual Function Index | 6 weeks postoperatively. | Female sexual function index on a scale of 2-36 with higher scores meaning higher sexual dysfunction |
| Percentage of Participants With Self Reported Pain Persistence | 6 months postoperatively. | The outcome of binary, subject pain persistence, assessed as yes or no, will be compared between groups using the Fisher exact test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORResad Pasic, MD, PhD
University of Louisville
Participant flow
Recruitment details
Excluded=64 Declined to participate=36 Did not meet inclusion criteria=28
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 72 Participants |
| Race/Ethnicity, Customized Non-White | 9 Participants |
| Race/Ethnicity, Customized White | 55 Participants |
| Region of Enrollment United States | 34 participants |
| Sex/Gender, Customized females analyzed | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 34 |
| other Total, other adverse events | 3 / 38 | 4 / 34 |
| serious Total, serious adverse events | 0 / 38 | 0 / 34 |
Outcome results
None listed