Clinical Trial

Glycemic Regulation as Endometriosis Adjunct Treatment

Study acronym: GREAT
Active, Not Recruiting Phase 2
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Summary
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
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-17
Trial Details
NCT Number NCT06611501
Lead Sponsor Boston Children's Hospital
Conditions Pelvic Pain, Endometriosis
Enrollment 14 participants
Start Date 2025-05-22
Primary Completion 2027-01 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2026-07-16