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NCT06611501

Glycemic Regulation as Endometriosis Adjunct Treatment

Active, Not Recruiting
PHASE2Ages 15–35InterventionalTreatment
Boston Children's Hospital
~14 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:Metformin HydrochloridePlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months
Measured over once at each of the three visits (at baseline, 3 months, 6 months)
+3 more outcomes measured

Conditions

Pelvic Pain
Endometriosis

Explore related trials

Endometriosis

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Jessica Shim, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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

What this trial measures

  • Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 monthsonce at each of the three visits (at baseline, 3 months, 6 months)

    The BPI Interference Scale is a 7-item composite pain measurement. This self-report measure assesses the extent to which pain interferes with various components of physical and emotional functioning and sleep. The items in this scale can be grouped into those that assess physical functioning (general activity; walking ability; normal work, including both work outside the home and housework), those that assess emotional functioning (mood; relations with people; enjoyment of life), and a single item that assess the extent to which pain interferes with sleep. The arithmetic mean of the seven interference items can be used as a measure of pain interference. The BPI is anchored between a scale of zero (no pain/interference) to ten (maximum pain/interference). The magnitude of treatment-associated change in BPI Interference Scale scores in open-label and randomized clinical trials ranges from 1 to 3 points, depending on the specific pain conditions and treatments studied.

  • Change in pain severity measured by Visual Analog Scale (VAS) over 6 monthsonce at each of the three visits (at baseline, 3 months, 6 months)

    VAS: A measurement of pain intensity, assessed by a 0 to 10 numerical rating scale, to rate maximum and average pain intensity over the preceding 7 days. Higher scores indicate more severe pain intensity.

  • Change in emotional functioning assessed by Beck Depression Inventory-II (BDI) over 6 monthsonce at each of the three visits (at baseline, 3 months, 6 months)

    The BDI is a 21-item self-report instrument that provides a rapid assessment of depressive symptoms. BDI has been used in many studies of chronic pain, including chronic pelvic pain and endometriosis. Total scores on the BDI range from 0 to 63. The BDI takes about 5-10 minutes to complete. Scores below 13 should be considered to reflect "minimal or no" depression, with score ranges of 14 to 19, 20 to 28, and 29 to 63 reflect "mild to moderate," "moderate to severe," and "severe" depression, respectively.

  • Change in ratings of overall improvement assessed by the Patient Global Impression of Change scale (PGIC)once at each of the three visits (at baseline, 3 months, 6 months)

    The PGIC is a seven-point single-item scale with options ranging from 'very much worse' to 'very much improved'. There has been widespread use of the PGIC in recent endometriosis clinical trials, as it readily interprets a person's evaluation of the importance of their improvement or worsening.