Status:
RECRUITING
Glycemic Regulation as Endometriosis Adjunct Treatment
Lead Sponsor:
Boston Children's Hospital
Conditions:
Pelvic Pain
Endometriosis
Eligibility:
FEMALE
15-35 years
Phase:
PHASE2
Brief 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 ...
Detailed 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, endometrios...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 22 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06611501
Start Date
May 22 2025
End Date
January 1 2027
Last Update
May 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115