Dysport in Vulvodynia Phase II Study

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.

Timeline

Start

2018-06-11

Primary completion

2021-01-21

Completion

2021-01-21

Outcome

Outcome not reported

Stopped: “lack of efficacy”

Publications

• Goldstein A, Rubin R, Dahir M, Goldstein I, Faught BM, Bohm-Starke N, Krapf J, Caetano P, Volteau M, Silva R. Phase 2 randomized study of abobotulinumtoxinA in patients with provoked vestibulodynia: dose-finding results. J Sex Med. 2025 Apr 15;22(4):588-596. doi: 10.1093/jsxmed/qdaf022.

Drugs

Indications