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Active Not Recruiting
NCT06611501
Glycemic Regulation as Endometriosis Adjunct Treatment
Conditions: Pelvic Pain, Endometriosis
Sex: Female
Ages: 15 Years – 35 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 14
Sponsor: Boston Children's Hospital
Location: Boston Children's Hospital Boston Massachusetts
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 Criteria
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 (NCT06611501). StuddyBuddy aggregates publicly available trial information.