Trial intelligence / Profile preview

Metformin for Pelvic Pain in Endometriosis

NCT06611501Phase 2

Key facts

Status: Active, not recruiting
Start: May 2025
Primary completion: Jan 2027
Countries: 1
Sponsor: Boston Children's Hospital
Modality: Small Molecules

Drugs: liquid metformin (Aspargo Labs)
Conditions: endometriosispelvic pain

Overview

Phase 2, randomised, double-blind trial of liquid metformin (Aspargo Labs) in endometriosis and pelvic pain (2 arms), sponsored by Boston Children's Hospital. Primary endpoints: Brief Pain Inventory Interference Scale at 6 months, Visual Analog Scale at 6 months and 2 more. Started May 2025; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Placebo
Placebo tablets orally daily for a total of 6 months of treatment.
Metformin
Metformin hydrochloride capsules daily for a total of 6 months of treatment, titrated from 500 mg/daily up to 2000 mg/daily.

Who it enrols

Females aged 15-35 with surgically confirmed endometriosis and current pelvic pain, who have been on consistent hormonal therapy for at least 2 months. Excludes patients with diabetes, severe renal dysfunction, or current/planned pregnancy.

Endpoints

Primary

Brief Pain Inventory Interference Scale6 months
Visual Analog Scale6 months
Beck Depression Inventory-II6 months
Patient Global Impression of Change scale6 months

Secondary

Endometriosis Health Profile-306 months
New Sexual Satisfaction Scale6 months
World Endometriosis Research Foundation questionnaire6 months
Serum angiogenic/inflammatory markers6 months

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