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

Inclusion criteria

• Participant with vulvodynia (provoked vestibulodynia).

Exclusion criteria

• 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.