Glycemic Regulation as Endometriosis Adjunct Treatment

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Boston Children's Hospital
RECRUITING
Boston
Contact Information
Primary
Ava Scatoni, MSPH
ava.scatoni@childrens.harvard.edu
6173557648
Backup
Jessica Shim, MD
Jessica.Shim@childrens.harvard.edu
6173557648
Time Frame
Start Date: 2025-05-22
Estimated Completion Date: 2027-01
Participants
Target number of participants: 14
Treatments
Placebo_comparator: Placebo
Placebo tablets orally daily for a total of 6 months of treatment.
Experimental: Metformin
metformin hydrochloride 500 mg capsules daily for a total of 6 months of treatment
Related Therapeutic Areas
Sponsors
Leads: Boston Children's Hospital

This content was sourced from clinicaltrials.gov