Glycemic Regulation as Endometriosis Adjunct Treatment

Launched by BOSTON CHILDREN'S HOSPITAL · Sep 20, 2024

Keywords

ClinConnect Summary

This clinical trial, called "Glycemic Regulation As Endometriosis Adjunct Treatment," is looking at whether a medication called metformin can help reduce pelvic pain in young women with endometriosis. The study aims to find out if metformin is more effective than a placebo (a harmless look-alike pill) in relieving pain and whether it can change certain markers of inflammation in the body over a period of six months.

To participate in this trial, you need to be a female between the ages of 15 and 35 who has been diagnosed with endometriosis through surgery and has been experiencing pelvic pain for at least two months. Participants will take either metformin or the placebo daily for six months and will visit the clinic three times during the study to check on progress. They will also keep a daily diary to record their pain levels and any medication they use. It's important to note that this trial is not yet recruiting participants, but it may be a useful option for those who qualify.

Gender

FEMALE

Eligibility criteria

• 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 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