Clinical Research Directory

Inclusion Criteria: * At least 3 months postpartum * Diagnosis of moderate to severe vulvodynia as defined by persistent vulvar pain for at least 3 months duration with an unclear etiology (defined by a minimum pain score at baseline using NRS and VPAQ questionnaires). * Prior therapy may include conservative management options (vulvar care guidelines, vaginal hormone therapy, neuromodulators etc.) Exclusion Criteria: * Pregnancy or breastfeeding. * Positive urine pregnancy test at study entrance, for subjects of childbearing potential * Unwillingness to use contraception during treatment and for one week after last dose if subject is of childbearing potential and sexually active with males. * Known hypersensitivity to naltrexone. * Prior or concurrent use of other systemic or topical treatments for vulvodynia (except topical hormonal therapy) within 3 months of enrollment. * Pelvic treatment with botulinum toxin injection within the last 12 months prior to the baseline visit * Use of opioids in any formulation (including pain medication, cough suppressants, and anti-diarrheal agents) within two weeks prior to study entrance. * Positive toxicology screen for opioids at study entrance. * Active gynecologic malignancy. * Elevated hepatic enzymes on screening laboratory assessment (ALT ≥1.5- fold ULN, AST ≥1.5-fold ULN, alkaline phosphatase ≥1.5-fold ULN, or/or total bilirubin ≥1.5-fold ULN, with the exception of known Gilbert's disease) * Known cirrhosis (compensated or decompensated) * Kidney disease defined as estimated glomerular filtration rate (eGFR) \< 60 ml/minute on screening laboratory assessment using the Cockcroft-Gault Formula. * Any history (past or current) of suicidal ideation or attempt. * Evidence of suicidal ideation on baseline screening using the Columbia Suicide Severity Rating Scale (C-SSRS). * Uncontrolled depression. * Unwillingness to refrain from driving/operating heavy machinery until the effect of the drug on drowsiness/somnolence is determined by the subject.