University of Florida
The goal of this observational pilot study is to assess the safety, efficacy, and tolerability of oral low dose naltrexone (LDN) in the treatment of vulvodynia. The aims it will address are: Aim 1:To assess the efficacy of LDN by reviewing patient-reported Global Treatment Improvement scale scores after the 4-week treatment period. Aim 2: To identify the impact on overall and vulvar pain by calculating the difference between average pre- and post-treatment PGIC, NRS, CSI and VPAQ scores. Aim 3: To identify adverse effects that patients may experience during treatment to better understand the safety profile of this medication. Participants will \[describe the main tasks participants will be asked to do, interventions they'll be given and use bullets if it is more than 2 items\] * Attend a baseline clinic visit and complete PGIC, NRS, VPAQ, and CSI questionnaires * Take 4.5 mg LDN once daily for 4 weeks * Discontinue LDN and contact the health care team immediately in the event of adverse effects * Attend a follow up appointment 4 weeks after medication initiation
1. Abstract: Vulvodynia is a chronic and often debilitating condition characterized by vulvar pain without an identifiable cause, affecting an estimated 9-12% of women. This condition significantly impacts a woman's quality of life, influencing sexual function, emotional well-being, and social relationships. Current treatment options, such as topical anesthetics, pelvic floor therapy, and oral medications, offer limited efficacy and can be associated with side effects, underscoring the need for alternative therapies. One promising treatment is low-dose naltrexone (LDN), traditionally used…
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 a…
4.5 mg oral LDN daily for four weeks
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