Dysport in Vulvodynia Phase II Study (DYVINIA)

Ipsen

Status and phase: Terminated; Phase 2

Conditions: Vulvodynia

Treatments: Drug: Placebo; Biological: Botulinum toxin type A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03598777

D-FR-52120-236

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

Dysport - Dose Escalation stage 1

Experimental group

Description:

Intramuscular injection of Dysport on day 1 of each cycle.

Treatment:

Biological: Botulinum toxin type A

Placebo - Dose Escalation stage 1 and Dose Expansion stage 2

Placebo Comparator group

Description:

Intramuscular injection on day 1 of cycle 1.

Treatment:

Drug: Placebo

Dysport - Dose Expansion stage 2

Active Comparator group

Description:

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.

Treatment:

Biological: Botulinum toxin type A