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Dysport in Vulvodynia Phase II Study

NCT03598777 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-12-09

Study results available
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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

  • Vulvodynia

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2021-01-21
Completion
2021-01-21
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03598777 on ClinicalTrials.gov