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Metformin for Endometriosis (GREAT Trial)

Phase 2
Waitlist Available
Led By Jessica Shim, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female with surgically confirmed endometriosis, determined at laparoscopy
Age 15 years to 35 years and premenopausal
Must not have
Pre-menarche or post-menopause
Severe renal dysfunction (creatinine >1.4 mg/dL or eGFR below 45 mL/minute/1.73 m2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up once at each of the three visits (at baseline, 3 months, 6 months)

Summary

This trial aims to see if metformin, a non-hormonal treatment, can help reduce pelvic pain in young women with endometriosis. Participants will take either metformin or a

Who is the study for?
This trial is for young women with endometriosis experiencing pelvic pain. Participants will take a daily dose of either metformin or placebo for 6 months and visit the clinic three times. They must keep a symptom diary. Specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study tests if metformin, a non-hormonal treatment, can alleviate pelvic pain in endometriosis better than a placebo. It also examines whether metformin affects inflammatory markers over the course of treatment.
What are the potential side effects?
While specific side effects are not listed, common ones associated with metformin include stomach upset, diarrhea, nausea/vomiting, and potential vitamin B12 deficiency with long-term use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman diagnosed with endometriosis through surgery.
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I am between 15 and 35 years old and have not gone through menopause.
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I have had pelvic pain rated 3 or higher for at least 2 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not started menstruating or I am post-menopausal.
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My kidney function is severely impaired.
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I have been diagnosed with Type 1 or Type 2 Diabetes.
Select...
I have had lactic acidosis or diabetic ketoacidosis before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~once at each of the three visits (at baseline, 3 months, 6 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and once at each of the three visits (at baseline, 3 months, 6 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in emotional functioning assessed by Beck Depression Inventory-II (BDI) over 6 months
Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months
Change in pain severity measured by Visual Analog Scale (VAS) over 6 months
+1 more
Secondary study objectives
Change in quality of life, measured via Endometriosis Health Profile-30 (EHP-30)
Changes in serum angiogenic/inflammatory markers
Changes in sexual satisfaction for participants who are sexually active measured by the New Sexual Satisfaction Scale
+1 more
Other study objectives
Change in pregnancy status
Changes in blood pressure
Changes in heart rate
+14 more

Side effects data

From 2023 Phase 2 trial • 40 Patients • NCT03733132
35%
Diarrhea
10%
Anemia
10%
Nausea
10%
Gastroesophageal reflux disease
5%
Pain
5%
Weight loss
5%
COVID-19 Infection
5%
Fall
5%
Flatulence
5%
Hepatobiliary disorders
5%
Social circumstances
5%
Vomiting
5%
Headache
5%
Stroke
5%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Metformin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MetforminExperimental Treatment1 Intervention
metformin hydrochloride 500 mg capsules daily for a total of 6 months of treatment
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablets orally daily for a total of 6 months of treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin Hydrochloride
2016
Completed Phase 4
~1990

Find a Location

Who is running the clinical trial?

Boston Children's HospitalLead Sponsor
782 Previous Clinical Trials
5,581,177 Total Patients Enrolled
4 Trials studying Pelvic Pain
4,037 Patients Enrolled for Pelvic Pain
Jessica Shim, MDPrincipal InvestigatorBoston Children's Hospital
~9 spots leftby Jan 2027
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