NCT06611501Active, not recruitingPhase 2
Glycemic Regulation as Endometriosis Adjunct Treatment
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 10 Sept 2024
- Start date
- 22 May 2025
- Primary completion date
- Jan 2027
- Lead sponsor
- Boston Children's Hospital
- Diseases
- Endometriosis
- NCT number
- NCT06611501
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 14
- From 22 May 2025 to the primary completion date, Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosis of Type 1 or Type 2 Diabetes Mellitus
- History of lactic acidosis or diabetic ketoacidosis
- Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study
Lab values
- Severe renal dysfunction (creatinine \>1.4 mg/dL or eGFR below 45 mL/minute/1.73 m2
- ALT or AST \> 2.5 times the upper limit of normal
Other
- Pre-menarche or post-menopause
- Current/planning pregnancy or breastfeeding
- Inability to read English
Who the study is looking for
- 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
Age in the registry: 15 years to 35 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.