Using metformin to treat pelvic pain in young women with endometriosis
Glycemic Regulation as Endometriosis Adjunct Treatment
This study is testing if the diabetes drug metformin can help young women with endometriosis feel less pelvic pain compared to a placebo.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 14 (estimated) |
| Ages | 15 Years to 35 Years |
| Sex | Female |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06611501 on ClinicalTrials.gov |
What this trial studies
This pilot trial aims to evaluate the effectiveness of metformin hydrochloride, a non-hormonal treatment, in alleviating pelvic pain in young women diagnosed with endometriosis. Participants will be randomly assigned to receive either metformin or a placebo for six months, during which they will track their symptoms and attend three clinic visits. The study will assess whether metformin is superior to placebo in reducing pain and whether it impacts systemic inflammatory markers over the treatment period.
Who should consider this trial
Good fit: Ideal candidates are premenopausal females aged 15 to 35 with surgically confirmed endometriosis and current pelvic pain.
Not a fit: Patients who are post-menopausal, pre-menarche, or have diabetes or severe renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new non-hormonal option for managing pelvic pain in young women with endometriosis.
How similar studies have performed: While the use of metformin for endometriosis is a novel approach, other studies have explored its effects on related conditions, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jessica Shim, MD — Boston Children's Hospital
- Study coordinator: Mari Garza, BA
- Email: GYNResearch@childrens.harvard.edu
- Phone: 6173557648
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.