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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Vulvodynia

In brief

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.

Key facts

Study ID

NCT07391241

Run by

Initiator Pharma

People needed

24

Starts

2025-12-17

Expected to finish

2026-12-01

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

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.

Where it is running

• MAC — Blackpool, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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