Glycemic Regulation as Endometriosis Adjunct Treatment
Boston Children's Hospital
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
Description
Endometriosis is a chronic illness defined by the presence of endometrial glands and stroma outside the uterine lining. While prevalence estimates vary depending on the population studied, endometriosis is thought to affect approximately one in ten reproductive aged women, up to 50% of women with infertility, and up to 70% of adolescents with chronic pelvic pain. Over 10 million women in the United States have endometriosis and incur significantly higher direct and indirect healthcare costs than those without. Annual health care costs are estimated at $100 billion in the United States alone. W…
Eligibility
- Age range
- 15–35 years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DrugMetformin 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.
- DrugPlacebo
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.
Location
- Boston Children's HospitalBoston, Massachusetts