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Glycemic Regulation as Endometriosis Adjunct Treatment (GREAT)
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
Details
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 14 |
| Start date | 2025-05-22 |
| Completion | 2027-01 |
Conditions
- Pelvic Pain
- Endometriosis
Interventions
- Metformin Hydrochloride
- Placebo
Primary outcomes
- Change in pain assessed by the Brief Pain Inventory Interference Scale (BPI) over 6 months — once 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 months — once 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 months — once 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.
Countries
United States