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).
1 other identifier
interventional
24
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2025
CompletedFirst Submitted
Initial submission to the registry
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
February 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 5, 2026
January 1, 2026
9 months
January 21, 2026
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
Dose_1
EXPERIMENTALPudafensine
Dose_2
EXPERIMENTALPudafensine
Dose_3
EXPERIMENTALPudafensine
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- Participant with vulvodynia (provoked vestibulodynia).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Initiator Pharmalead
Study Sites (1)
MAC
Blackpool, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Abimbola Babajide, Dr
MAC, UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
February 5, 2026
Study Start
December 17, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 5, 2026
Record last verified: 2026-01