Metformin for Endometriosis
(GREAT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJessica Shim, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Boston Children's Hospital

Prior Safety Data

Approved in 5 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this pilot trial is to learn if a novel non-hormonal treatment, metformin hydrochloride, works to treat pelvic pain in young women with endometriosis. The main questions it aims to answer are: * Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis? * Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis? Researchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain. Participants will: * Take drug metformin or a placebo every day for 6 months * Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months * Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications

Research Team

Jessica Shim, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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.

Inclusion Criteria

I have been on hormonal therapy for endometriosis for at least 2 months.

I have had pelvic pain rated 3 or higher for at least 2 months.

I am a woman diagnosed with endometriosis through surgery.

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Exclusion Criteria

ALT or AST > 2.5 times the upper limit of normal

Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study

Inability to read English

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Treatment Details

Interventions

Metformin Hydrochloride (Anti-diabetic agent)

Trial OverviewThe 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.

Participant Groups

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.