Glycemic Regulation as Endometriosis Adjunct Treatment

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Pelvic Pain, Endometriosis

In brief

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

Key facts

Study ID: NCT06611501
Run by: Boston Children's Hospital
People needed: 14
Starts: 2025-05-22
Expected to finish: 2027-01-01
Last updated by the study team: 2026-07-16

Who can join

Age: 15 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Female with surgically confirmed endometriosis, determined at laparoscopy
Current use for at least 2 months duration of a consistent hormonal therapy for endometriosis (either combination hormonal contraceptives or progestin-only therapy)
Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment
Age 15 years to 35 years and premenopausal
Willingness to comply with visit schedule and protocol

You may not qualify if…

Pre-menarche or post-menopause
Diagnosis of Type 1 or Type 2 Diabetes Mellitus
Severe renal dysfunction (creatinine \>1.4 mg/dL or eGFR below 45 mL/minute/1.73 m2
History of lactic acidosis or diabetic ketoacidosis
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
Current/planning pregnancy or breastfeeding
Inability to read English

Where it is running

Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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