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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Premenopausal - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dysport - Dose Escalation stage 1 		Intramuscular injection of Dysport on day 1 of each cycle.
  • Biological: Botulinum toxin type A
    Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
    Other names:
    • AbobotulinumtoxinA (Dysport®)
Placebo Comparator
Placebo - Dose Escalation stage 1 and Dose Expansion stage 2 		Intramuscular injection on day 1 of cycle 1.
  • Drug: Placebo
    The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
Active Comparator
Dysport - Dose Expansion stage 2 		Depending upon the results from Stage 1 one or two doses of Dysport will be selected. Intramuscular injection of Dysport on day 1 of each cycle.
  • Biological: Botulinum toxin type A
    Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
    Other names:
    • AbobotulinumtoxinA (Dysport®)

More Details

Status
Terminated
Sponsor
Ipsen

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.