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).

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.

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.