Glycemic Regulation as Endometriosis Adjunct Treatment
United States14 participantsStarted 2025-05-22
Plain-language 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
Who can participate
Age range
15 Years – 35 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months
Timeframe: once at each of the three visits (at baseline, 3 months, 6 months)
2
Change in pain severity measured by Visual Analog Scale (VAS) over 6 months
Timeframe: once at each of the three visits (at baseline, 3 months, 6 months)
3
Change in emotional functioning assessed by Beck Depression Inventory-II (BDI) over 6 months
Timeframe: once at each of the three visits (at baseline, 3 months, 6 months)
4
Change in ratings of overall improvement assessed by the Patient Global Impression of Change scale (PGIC)
Timeframe: once at each of the three visits (at baseline, 3 months, 6 months)