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NCT03598777 · ClinicalTrials.gov registry record · Phase 2
Dysport in Vulvodynia Phase II Study
A Phase 2 study, sponsored by Ipsen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT03598777: Clinical Trial Phase 2 study, sponsored by Ipsen.
NCT03598777 is a Phase 2 study that was terminated before completion, run by Ipsen. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03598777, a Phase 2 study, was terminated before completion, sponsored by Ipsen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
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.
Primary Outcome
For Stage 1, the primary endpoint was safety during the DB treatment period as assessed by the incidence of adverse events (AEs). An AE was the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product. An undesirable medical condition could have been symptoms, signs or abnormal results of an investigation. A TEAE was an event with sta
Interventions
- DRUG Placebo
- BIOLOGICAL Botulinum toxin type A
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-06-11 |
| Est. Completion | 2021-01-21 |
| Phase | Phase 2 |
Why NCT03598777 stopped before completion
NCT03598777 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03598777 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03598777 about?
NCT03598777 is a clinical study titled "Dysport in Vulvodynia Phase II Study". 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-b...
What is the current status of trial NCT03598777?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2018-06-11. Estimated completion is 2021-01-21.
What interventions are being tested in trial NCT03598777?
The interventions under investigation include: Placebo (DRUG), Botulinum toxin type A (BIOLOGICAL).
Who is sponsoring clinical trial NCT03598777?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03598777's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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