Actively Recruiting
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)
Led by Initiator Pharma · Updated on 2026-02-05
24
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase 2 randomized, double-blind, placebo-controlled, 4-way cross-over trial to study the effects of pudafensine on vulvodynia, specifically provoked vestibulodynia. The goal is to evaluate the safety and efficacy of a single dose of pudafensine in reducing pain in the vaginal vestibule. This study aims to better understand how pudafensine affects vestibular pain threshold in patients with this condition. Participants receive single doses of pudafensine or placebo in a randomized sequence across four treatment periods. The study includes three different doses of pudafensine and one placebo group, with each participant experiencing all four treatments at different times. The crossover design allows comparison of the drug's impact versus placebo within the same individuals. During the study, participants undergo the Vestibular Pain Threshold Test to measure pain changes in the vaginal vestibule. This evaluation continues through study completion, averaging about one year. Safety and pain response are monitored throughout the trial. Participants are women aged 18 to 65 diagnosed with vulvodynia, and the study excludes those with certain other vulvar or pelvic conditions that could affect pain assessment.
CONDITIONS
Brief 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).
- Female aged 18 to 65 years.
You will not qualify if you...
- Vulvar pain caused by specific disorders including infectious (e.g. recurrent candidiasis, herpes).
- Inflammatory vulvar conditions (e.g. lichen sclerosus, lichen planus, immunobullous disorders).
- Neoplastic vulvar diseases (e.g. Paget disease, squamous cell carcinoma).
- Neurologic causes of vulvar pain (e.g. postherpetic neuralgia, nerve injury).
- Trauma-related vulvar pain (e.g. female genital cutting, obstetrical trauma).
- Iatrogenic causes (e.g. postoperative, chemotherapy, radiation).
- Hormonal deficiencies causing vulvar pain (e.g. genitourinary syndrome of menopause, lactational amenorrhea).
- History or current diagnosis of significant pelvic floor dysfunction.
- Co-morbid pelvic pain conditions such as 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year through study completion
Participants receive single doses of Pudafensine or placebo in a randomized, double-blind, 4-way crossover design.
4 dosing visits (in-person) with washout periods in between
Trial Site Locations
Total: 1 location
1
MAC
Blackpool, United Kingdom
Actively Recruiting
Research Team
A
Abimbola Babajide, Dr, MBCHB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here