Low-dose Naltrexone Treatment for Pain Relief and Quality of Life Improvement in Women With Vulvodynia

What this Trial Is About

This research aims to evaluate the effect of low-dose naltrexone LDN on pain perception and quality of life in women suffering from different types of vulvodynia, a chronic vulvar pain condition with no established pharmacologic treatments. The study is a randomized controlled trial with quadruple blinding, designed to compare the effects of LDN against placebo in women aged 18 to 50 years. Vulvodynia significantly impacts quality of life, and this trial investigates whether LDN can reduce pain and improve emotional well-being over four months of treatment. Participants are randomly assigned to receive either a daily oral dose of 4.5 mg naltrexone hydrochloride or a matching placebo for four months. The trial includes five visits involving a gynecologist, nurse, psychologist, and physiotherapist for diagnosis, screening, randomization, treatment monitoring, and final assessment. The study follows the IMMPACT protocol and includes assessments using validated psychological questionnaires and physical examinations according to the Fascial Manipulation method. During participation, women will record pain levels and quality of life in an electronic diary and complete questionnaires to evaluate emotional functioning and satisfaction with treatment. The study team will monitor tolerability and side effects throughout the treatment period. Follow-up includes a telephone summary visit after treatment completion. The primary outcomes focus on changes in pain intensity, pain type and severity, emotional functioning, and patient satisfaction over four months of treatment.

Effectiveness of Low-dose Naltrexone in Patients With Different Types of Vulvodynia