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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 is a Phase 2 study that was terminated before completion, run by Ipsen. The registered enrollment target is 60 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03598777
The ClinicalTrials.gov registry entry for NCT03598777 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03598777 reports 0 study locations.
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.
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