U.S., Dec. 3 -- ClinicalTrials.gov registry received information related to the study (NCT07257029) titled 'Topical Ketotifen 0.25% for Secondary Vestibulodynia' on Nov. 21.
Brief Summary: This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of topical ketotifen fumarate 0.25% cream in adult women with secondary provoked vestibulodynia (PVD). Secondary PVD is a chronic vulvar pain condition characterized by burning or sharp pain with vaginal penetration (e.g., intercourse, tampon use) and touch of the vulvar vestibule, often following recurrent infections or topical irritant exposures. Preclinical studies suggest that ketotifen, a mast-cell stabilizer and histamine H1 antago...