Glycemic Regulation as Endometriosis Adjunct Treatment
Eligible age
15–35 yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Boston Children's Hospital
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's recruiting
Boston
Source: ClinicalTrials.gov · NCT06611501 · last updated 2026-02-20