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RECRUITING
NCT06611501
PHASE2

Glycemic Regulation as Endometriosis Adjunct Treatment

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

FEMALE

Age Range

15 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

14

Start Date

2025-05-22

Completion Date

2027-01

Last Updated

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

Metformin Hydrochloride

Metformin dosage titrated from 500 mg/daily for 2 weeks, then 1000 mg/daily for 2 weeks, 1500 mg/daily for 2 weeks, and then achieving 2000 mg/daily for a duration of 6 months of treatment.

DRUG

Placebo

1 tablet orally with evening meal for 2 weeks, then 1 tablet twice daily for 2 weeks, then 3 tablets split twice daily for 2 weeks, then 4 tablets split twice daily, for a total of 6 months of treatment.

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States