A Phase II, Multicenter, Double-blind, Randomized, Placebo-controlled, Dose Escalation and Dose Finding Study to Evaluate the Efficacy and Safety of Dysport in Vulvodynia Patients
- 18 – 45 years old
- Have vulvodynia with provoked vestibular pain 6 months – 15 years
- Willing to abstain from physical therapy/sex therapy 6 weeks after first treatment
The purpose of this research study is to evaluate the efficacy, safety and identify the optimal doses of Dysport in the treatment of vulvodynia. In this study, Dysport will be compared to a placebo treatment. Previous studies for vulvodynia and other related conditions such as vaginismus have shown that Dysport or other Botulinum toxin A preparations such as Botox relax the pelvic floor muscles and decrease pain.
If you are interested in participating in our clinical trial, please read the informed consent.