Overview

Dysport in Vulvodynia Phase II Study

Status:
Terminated
Trial end date:
2021-01-21
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Ipsen
Treatments:
abobotulinumtoxinA
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA