Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
60 participants
INTERVENTIONAL
2018-06-11
2021-01-21
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Dysport - Dose Escalation stage 1
Intramuscular injection of Dysport on day 1 of each cycle.
Botulinum toxin type A
Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
Placebo - Dose Escalation stage 1 and Dose Expansion stage 2
Intramuscular injection on day 1 of cycle 1.
Placebo
The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
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.
Botulinum toxin type A
Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
Interventions
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Botulinum toxin type A
Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
Placebo
The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Ipsen
INDUSTRY
Responsible Party
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Principal Investigators
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Ipsen Medical Director
Role: STUDY_DIRECTOR
Ipsen
Locations
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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
Countries
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References
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Goldstein A, Rubin R, Dahir M, Goldstein I, Faught BM, Bohm-Starke N, Krapf J, Caetano P, Volteau M, Silva R. Phase 2 randomized study of abobotulinumtoxinA in patients with provoked vestibulodynia: dose-finding results. J Sex Med. 2025 Apr 15;22(4):588-596. doi: 10.1093/jsxmed/qdaf022.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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D-FR-52120-236
Identifier Type: -
Identifier Source: org_study_id