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Dysport in Vulvodynia Phase II Study — DYVINIA  

Vulvodynia Clinical Trial

Official title:
A Phase II, Multicentre, Double-blind, Randomised, Placebo Controlled, Dose Escalation and Dose Finding Study to Evaluate the Efficacy and Safety of Dysport in Vulvodynia Patients

Clinical Trial Summary

This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia. The study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Both Stage 1 and Stage 2 will consist of a double-blind period (with treatment cycle 1; Dysport or placebo) followed by an open label treatment period. One or two optimally safe and effective doses of Dysport selected from Stage 1 will be further investigated in the Stage 2.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03598777
Study type Interventional
Source Ipsen
Contact
Status Terminated
Phase Phase 2
Start date June 11, 2018
Completion date January 21, 2021
View Details
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