RECRUITING

Glycemic Regulation as Endometriosis Adjunct Treatment

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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

Official Title

Glycemic Regulation as Endometriosis Adjunct Treatment

Quick Facts

Study Start:2025-05-22
Study Completion:2027-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06611501

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.

Ages Eligible for Study:15 Years to 35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female with surgically confirmed endometriosis, determined at laparoscopy
  2. * Current use for at least 2 months duration of a consistent hormonal therapy for endometriosis (either combination hormonal contraceptives or progestin-only therapy)
  3. * Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment
  4. * Age 15 years to 35 years and premenopausal
  5. * Willingness to comply with visit schedule and protocol
  1. * Pre-menarche or post-menopause
  2. * Diagnosis of Type 1 or Type 2 Diabetes Mellitus
  3. * Severe renal dysfunction (creatinine \>1.4 mg/dL or eGFR below 45 mL/minute/1.73 m2
  4. * History of lactic acidosis or diabetic ketoacidosis
  5. * ALT or AST \> 2.5 times the upper limit of normal
  6. * Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study
  7. * Current/planning pregnancy or breastfeeding
  8. * Inability to read English

Contacts and Locations

Study Contact

Ava Scatoni, MSPH
CONTACT
6173557648
ava.scatoni@childrens.harvard.edu
Jessica Shim, MD
CONTACT
6173557648
Jessica.Shim@childrens.harvard.edu

Principal Investigator

Jessica Shim, MD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Boston Children's Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-22
Study Completion Date2027-01

Study Record Updates

Study Start Date2025-05-22
Study Completion Date2027-01

Terms related to this study

Keywords Provided by Researchers

  • Pelvic pain
  • Pain
  • Metformin
  • Chronic pain
  • Physiological Effects of Drugs
  • Endometriosis
  • Female Urogenital Diseases
  • Genital Diseases, Female

Additional Relevant MeSH Terms

  • Pelvic Pain
  • Endometriosis