Ireland
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Recruiting Phase 2

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

NCT07391241 · tracked via the Priya Life Science UK tracker
Sponsor
Initiator Pharma
Phase
Phase 2
Started
2025-12-17
Last updated
2026-02-05

Condition(s) studied

Vulvodynia

Investigational drug(s) / intervention(s)

Pudafensine

Pudafensine: Pudafensine

Study 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

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Participant with vulvodynia (provoked vestibulodynia). Exclusion Criteria: * Women with vulvar pain caused by a specific disorder: 1. Infectious (e.g. recurrent candidiasis, herpes). 2. Inflammatory (e.g. lichen sclerosus, lichen planus, immunobullous disorders). 3. Neoplastic (e.g. Paget disease, squamous cell carcinoma). 4. Neurologic (e.g. postherpetic neuralgia, nerve compression or injury, neuroma). 5. Trauma (e.g. female genital cutting, obstetrical). 6. Iatrogenic (e.g. postoperative, chemotherapy, radiation). 7. 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.

Primary outcome measure(s)

  • 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 — Through study completion, an average of 1 year

Trial sites (1)

FacilityCityRegionStatus
MAC Blackpool United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07391241 on ClinicalTrials.gov ↗ ← All trials in the UK