A Phase 2 Study to Evaluate the Efficacy and Safety of Pudafensine in Vulvodynia (Provoked Vestibulodynia)
Recruiting
Phase 2
Interventional Study
Vulvodynia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 24 (estimated)
- Sponsor
- Initiator Pharma · Industry
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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.
Trial Locations
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Eligibility Criteria
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. N…
Contacts