Glycemic Regulation as Endometriosis Adjunct Treatment
Active, not recruitingPhase 2NCT06611501
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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
Study details
- Official title
- Glycemic Regulation as Endometriosis Adjunct Treatment
- Conditions
- Interventions
- Drug: Metformin Hydrochloride
- Drug: Placebo
- Sponsor
- Boston Children's Hospital
- Start date
- 2025-05-22
- Primary completion
- 2027-01
- Sex
- Female
- Age range
- from 15 Years to 35 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06611501