[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563079":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":61,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Boston Children's Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","Placebo tablets orally daily for a total of 6 months of treatment.",[13],"Drug: Placebo",{"label":15,"type":16,"description":17,"interventionNames":18},"Metformin","EXPERIMENTAL","metformin hydrochloride 500 mg capsules daily for a total of 6 months of treatment",[19],"Drug: Metformin Hydrochloride",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Metformin Hydrochloride","Metformin dosage titrated from 500 mg\u002Fdaily for 2 weeks, then 1000 mg\u002Fdaily for 2 weeks, 1500 mg\u002Fdaily for 2 weeks, and then achieving 2000 mg\u002Fdaily for a duration of 6 months of treatment.",[15],null,{"type":22,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"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.",[9],[31],"Placebo capsule",[33],{"name":34,"affiliation":5,"role":35},"Jessica Shim, MD","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Mari Garza, BA","CONTACT","6173557648","GYNResearch@childrens.harvard.edu",{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-71.05977,42.35843,{"lat":55,"lon":54},[58,60],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":59},"Jessica.Shim@childrens.harvard.edu",{"name":34,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jessica Shim","Assistant Professor, Division of Gynecology","100563079","phase-2-glycemic-regulation-as-endometriosis-adjunct-treatment-100563079",false,"NCT06611501","Glycemic Regulation as Endometriosis Adjunct Treatment","GREAT","Inclusion Criteria:\n\n* Female with surgically confirmed endometriosis, determined at laparoscopy\n* Current use for at least 2 months duration of a consistent hormonal therapy for endometriosis (either combination hormonal contraceptives or progestin-only therapy)\n* Current pelvic pain (score ≥ 3 on Visual Analog Scale) that has been present for at least 2 months prior to enrollment\n* Age 15 years to 35 years and premenopausal\n* Willingness to comply with visit schedule and protocol\n\nExclusion Criteria:\n\n* Pre-menarche or post-menopause\n* Diagnosis of Type 1 or Type 2 Diabetes Mellitus\n* Severe renal dysfunction (creatinine \\>1.4 mg\u002FdL or eGFR below 45 mL\u002Fminute\u002F1.73 m2\n* History of lactic acidosis or diabetic ketoacidosis\n* ALT or AST \\> 2.5 times the upper limit of normal\n* Significant mental or chronic systemic illness that might confound pain assessment or the inability to complete the study\n* Current\u002Fplanning pregnancy or breastfeeding\n* Inability to read English","FEMALE","15 Years","35 Years",{"count":75,"type":76},14,"ESTIMATED","INTERVENTIONAL",[79],"PHASE2","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:\n\n* Is metformin superior to placebo in alleviating pain symptoms in young women with endometriosis?\n* Does metformin alter systemic inflammatory markers over 6 months in young women with endometriosis?\n\nResearchers will compare metformin to a placebo (a look-alike substance that contains no drug) to see if metformin works to treat pelvic pain.\n\nParticipants will:\n\n* Take drug metformin or a placebo every day for 6 months\n* Visit the clinic three times: once at baseline (pre-treatment), once at 3 months, and once at 6 months\n* Keep a daily symptom diary to track pain, bleeding, and usage of any pain medications",[82,83],"Pelvic Pain","Endometriosis",[85,86,15,87,88,83,89,90],"Pelvic pain","Pain","Chronic pain","Physiological Effects of Drugs","Female Urogenital Diseases","Genital Diseases, Female","2026-02-18",{"date":93,"type":94},"2026-02-20","ACTUAL",{"date":96,"type":94},"2025-05-22",{"date":98,"type":76},"2027-01",{"name":5,"class":6},1]