Dysport in Vulvodynia Phase II Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/6/2019 |
| Start Date: | June 15, 2018 |
| End Date: | December 31, 2020 |
| Contact: | Ipsen Recruitment Enquiries |
| Email: | clinical.trials@ipsen.com |
A Phase II, Multicentre, Double-blind, Randomised, Placebo Controlled, Dose Escalation and Dose Finding Study to Evaluate the Efficacy and Safety of Dysport in Vulvodynia Patients
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.
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.
Inclusion Criteria:
- Have never had a vaginal delivery including attempted vaginal delivery
- 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
We found this trial at
10
sites
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