A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
ConditionVulvodynia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorInitiator Pharma
About this trial
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.
Eligibility criteria
Qualifiers
Participant with vulvodynia (provoked vestibulodynia).
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Pudafensine
Treatment groups
24 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov