Dysport in Vulvodynia Phase II Study

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Vulvodynia

In brief

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.

Key facts

Study ID

NCT03598777

Run by

Ipsen

People needed

60

Starts

2018-06-11

Expected to finish

2021-01-21

Last updated by the study team

2021-12-09

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• James A. Simon, MD, PC — Washington D.C., District of Columbia, United States
• The Center for Vulvovaginal Disorders — Washington D.C., District of Columbia, United States
• New Age Medical Research Corporation — Miami, Florida, United States
• University of Kansas Medical Center — Kansas City, Missouri, United States
• Omaha OB-GYN Associates, PC — Omaha, Nebraska, United States
• The Center for Vulvovaginal Disorders — New York, New York, United States
• Women's Institute for Sexual Health (WISH) — Nashville, Tennessee, United States
• Seattle Women's: Health, Research, Gynecology® — Seattle, Washington, United States
• Clinique de Santé des Femmes — Québec, Canada

Full record on ClinicalTrials.gov

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