Actively Recruiting
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Led by Initiator Pharma · Updated on 2026-02-05
24
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant with vulvodynia (provoked vestibulodynia).
You will not qualify if you...
- Women with vulvar pain caused by a specific disorder such as infectious (e.g., recurrent candidiasis, herpes).
- Women with vulvar pain caused by inflammatory conditions (e.g., lichen sclerosus, lichen planus, immunobullous disorders).
- Women with vulvar pain caused by neoplastic conditions (e.g., Paget disease, squamous cell carcinoma).
- Women with vulvar pain caused by neurologic conditions (e.g., postherpetic neuralgia, nerve compression or injury, neuroma).
- Women with vulvar pain caused by trauma (e.g., female genital cutting, obstetrical).
- Women with vulvar pain caused by iatrogenic causes (e.g., postoperative, chemotherapy, radiation).
- Women with vulvar pain caused by hormonal deficiencies (e.g., genitourinary syndrome of menopause, lactational amenorrhea).
- History or current diagnosis of significant pelvic floor dysfunction.
- Co-morbid pelvic pain conditions including pain due to pelvic fractures, pelvic girdle pain, or post-partum pelvic pain.
- History or current diagnosis of pelvic inflammatory disease.
- History or current diagnosis of endometriosis.
- History or current diagnosis of interstitial cystitis.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
MAC
Blackpool, United Kingdom
Actively Recruiting
Research Team
A
Abimbola Babajide, Dr, MBCHB
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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