Trials / Terminated
TerminatedNCT03598777
Dysport in Vulvodynia Phase II Study
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Ipsen · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A | Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles. |
| DRUG | Placebo | The reconstituted solution will be injected intramuscularly across pelvic floor muscles. |
Timeline
- Start date
- 2018-06-11
- Primary completion
- 2021-01-21
- Completion
- 2021-01-21
- First posted
- 2018-07-26
- Last updated
- 2021-12-09
- Results posted
- 2021-12-09
Locations
9 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03598777. Inclusion in this directory is not an endorsement.