Glycemic Regulation as Endometriosis Adjunct Treatment

Description

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

Pelvic Pain, Endometriosis

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Study Overview

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Study Details

Study overview

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

Glycemic Regulation as Endometriosis Adjunct Treatment

Glycemic Regulation as Endometriosis Adjunct Treatment

Condition
Pelvic Pain
Intervention / Treatment

-

Contacts and Locations

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

15 Years to 35 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Boston Children's Hospital,

Jessica Shim, MD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

2027-01