NCT07391241

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

A Randomised, Double-blind, Placebo-controlled, 4-way Cross-over Trial Studying the Efficacy and Safety of Single Dose Administration of Pudafensine in Vulvodynia (Provoked Vestibulodynia).

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Initiator Pharma · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study (IP2015CS05) is a randomised, double-blind, placebo-controlled, 4-way cross-over trial studying the efficacy and safety of single dose administration of pudafensine in vulvodynia (provoked vestibulodynia) patients.

Conditions

• Vulvodynia

Interventions

Type	Name	Description
DRUG	Pudafensine	Pudafensine

Timeline

• Start date: 2025-12-17
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2026-02-05
• Last updated: 2026-02-05

Locations

1 site across 1 country: United Kingdom