Glycemic Regulation as Endometriosis Adjunct Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age15-35
SponsorBoston Children's Hospital
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Metformin Hydrochloride
- Placebo
Treatment groups
14 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov