Actively Recruiting
Glycemic Regulation as Endometriosis Adjunct Treatment
Led by Boston Children's Hospital · Updated on 2026-02-20
14
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Glycemic Regulation as Endometriosis Adjunct Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female with surgically confirmed endometriosis diagnosed by laparoscopy
- Using consistent hormonal therapy for endometriosis for at least 2 months (combination hormonal contraceptives or progestin-only therapy)
- Current pelvic pain with a score of 3 or higher on the Visual Analog Scale for at least 2 months prior to enrollment
- Age between 15 and 35 years and premenopausal
- Willingness to follow study visit schedule and protocol
You will not qualify if you...
- Being pre-menarche or post-menopausal
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- Severe kidney problems (creatinine >1.4 mg/dL or eGFR below 45 mL/min/1.73 m2)
- History of lactic acidosis or diabetic ketoacidosis
- Elevated liver enzymes (ALT or AST more than 2.5 times the upper limit of normal)
- Significant mental or chronic systemic illness affecting pain assessment or ability to complete the study
- Current or planned pregnancy or breastfeeding
- Inability to read English or follow study procedures reliably
The trial compares metformin hydrochloride to a placebo over six months. Participants will take metformin starting at 500 mg daily for two weeks, increasing every two weeks to reach 2000 mg daily, or matching placebo tablets with a similar schedule. They will attend clinic visits at the start, 3 months, and 6 months to assess pain and emotional functioning.
Participants will keep daily diaries tracking symptoms like pain, bleeding, and pain medication use. Researchers will measure changes in pain interference, pain severity, emotional health using questionnaires, and overall improvement at each visit. The study monitors safety and evaluates whether metformin affects systemic inflammation and improves quality of life in young women with endometriosis over the 6-month treatment period.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Mari Garza, BA
CONTACT
J
Jessica Shim, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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