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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Pudafensine
DrugPudafensine
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: Dose_1Experimental treatment 1 intervention
Group B: Dose_2Experimental treatment 1 intervention
Group C: Dose_3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The primary objective of this study is to evaluate the effect of pudafensine on pain in the vaginal vestibule (vestibular pain threshold) using the Vestibular Pain Threshold Test
Time frame
Through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov