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.
|Treatment||Placebo, Botulinum Toxin Type A, Botulinum Toxin Type A (Dysport)|
|Clinical Study Identifier||NCT03598777|
|Last Modified on||2 December 2020|
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