Dysport in Vulvodynia Phase II Study

• Status: Terminated
• Trial end date: 2021-01-21
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• Premenopausal

• Have vulvodynia for at least 6 months and for no more than 15 years

• Have provoked pain at the vestibule on a Q tip test

Exclusion Criteria:

• Deep pain during intercourse

• Have genitourinary or gastrointestinal conditions which may interfere with the study

• Previous surgery that according to investigator's judgement may impact on study outcome (including but not limited to hysterectomy, vestibulectomy, urologic surgery, perianal surgery) or genital trauma or mutilation/cutting