Phase 2 Study of Pudafensine for Treating Vulvodynia Provoked Vestibulodynia in Women Aged 18 to 65

What this Trial Is About

Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled, 4-way cross-over trial to study the effects of pudafensine on vulvodynia, specifically provoked vestibulodynia. The goal is to evaluate the safety and efficacy of a single dose of pudafensine in reducing pain in the vaginal vestibule. This study aims to better understand how pudafensine affects vestibular pain threshold in patients with this condition. Participants receive single doses of pudafensine or placebo in a randomized sequence across four treatment periods. The study includes three different doses of pudafensine and one placebo group, with each participant experiencing all four treatments at different times. The crossover design allows comparison of the drugs impact versus placebo within the same individuals. During the study, participants undergo the Vestibular Pain Threshold Test to measure pain changes in the vaginal vestibule. This evaluation continues through study completion, averaging about one year. Safety and pain response are monitored throughout the trial. Participants are women aged 18 to 65 diagnosed with vulvodynia, and the study excludes those with certain other vulvar or pelvic conditions that could affect pain assessment.

A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)