Glycemic Regulation as Endometriosis Adjunct Treatment
Boston Children's Hospital
14 participants
May 22, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria8
- 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
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Interventions
Metformin dosage titrated from 500 mg/daily for 2 weeks, then 1000 mg/daily for 2 weeks, 1500 mg/daily for 2 weeks, and then achieving 2000 mg/daily for a duration of 6 months of treatment.
1 tablet orally with evening meal for 2 weeks, then 1 tablet twice daily for 2 weeks, then 3 tablets split twice daily for 2 weeks, then 4 tablets split twice daily, for a total of 6 months of treatment.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06611501