Pudafensine for vulvar pain in 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).

This trial tests whether a single dose of pudafensine reduces vulvar pain in people with provoked vestibulodynia.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: Initiator Pharma (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Blackpool)
• Trial ID: NCT07391241 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, four-way crossover Phase 2 trial in which each participant receives single doses of pudafensine and placebo in separate periods. Pain outcomes and safety measures are recorded after each dosing period to compare active drug with placebo within the same participants. Washout periods separate dosing periods to limit carryover effects. The design is intended to detect short-term analgesic effects and gather safety data in women with provoked vestibulodynia.

Who should consider this trial

Good fit: Adult women with provoked vestibulodynia whose pain is not explained by infections, dermatologic, neurologic, neoplastic, hormonal, traumatic, or iatrogenic causes and who do not have significant pelvic floor dysfunction or other co-morbid pelvic pain conditions.

Not a fit: People whose vulvar pain is due to specific excluded disorders (for example recurrent infections, lichen sclerosus, neurologic injury, neoplasia, hormonal atrophy), or who have significant pelvic floor dysfunction, pelvic inflammatory disease, or other confounding pelvic pain conditions, are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, pudafensine could provide a new, fast-acting treatment option to reduce provoked vulvar pain and improve sexual function and quality of life.

How similar studies have performed: Pudafensine has limited prior clinical data in vulvodynia, so this is a relatively novel approach, although other neuropathic-pain treatments for vulvar pain have had mixed results.

Eligibility criteria

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.

Where this trial is running

Blackpool

• Mac — Blackpool, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Abimbola Babajide, Dr — Mac, UK
• Study coordinator: Abimbola Babajide, Dr, MBCHB

Conditions Vulvodynia