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
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participant with vulvodynia (provoked vestibulodynia).
Locations
Other Locations
United Kingdom
MAC
RECRUITING
Blackpool
Contact Information
Primary
Abimbola Babajide, Dr, MBCHB
abimbolababajide@macplc.com
+44 01253444451
Time Frame
Start Date: 2025-12-17
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 24
Treatments
Experimental: Dose_1
Pudafensine
Experimental: Dose_2
Pudafensine
Experimental: Dose_3
Pudafensine
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: Initiator Pharma