A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pudafensine.
- Who it may be relevant to
- Registry conditions: Vulvodynia. Basic parameters: 18 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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).
Overview
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.
Interventions
- Drug Pudafensine
Pudafensine
Primary outcome measures
- The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test [Time frame: Through study completion, an average of 1 year]
Eligibility criteria
Inclusion criteria
- Participant with vulvodynia (provoked vestibulodynia).
Exclusion criteria
- Women with vulvar pain caused by a specific disorder:
- Infectious (e.g. recurrent candidiasis, herpes).
- Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
- Neoplastic (e.g. Paget disease, squamous cell carcinoma).
- Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma).
- Trauma (e.g. female genital cutting, obstetrical).
- Iatrogenic (e.g. postoperative, chemotherapy, radiation).
- Hormonal deficiencies (e.g. genitourinary syndrome of menopause (vulvovaginal atrophy), 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 (to avoid confounding pain outcomes).
- History or current diagnosis of pelvic inflammatory disease.
- History or current diagnosis of endometriosis.
- History or current diagnosis of interstitial cystitis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United Kingdom · 1 center
- MAC — Blackpool
Identifiers
NCT: NCT07391241 · IP2015CS05