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Dysport in Vulvodynia Phase II Study (DYVINIA)

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ClinicalTrials.gov Identifier: NCT03598777
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ipsen

Brief 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.


Condition or disease Intervention/treatment Phase
Vulvodynia Biological: Botulinum toxin type A Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, Multicentre, Double-blind, Randomised, Placebo Controlled, Dose Escalation and Dose Finding Study to Evaluate the Efficacy and Safety of Dysport in Vulvodynia Patients
Actual Study Start Date : June 15, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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 Name: 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 Name: AbobotulinumtoxinA (Dysport®)




Primary Outcome Measures :
  1. Safety: Incidence of any Dose Limiting Events (DLE) - stage 1 [ Time Frame: From Baseline to Cycle 1 Week 6 (each cycle is 12 weeks minimum) ]
  2. Mean change from Baseline to Cycle 1 to Week 6 in vaginal pain as reported on a 11-point pain Numeric Rating Scale (NRS) (scoring 0-no pain to 10-worst possible pain) - stage 2 [ Time Frame: Change from Baseline to Cycle 1 Week 6 (each cycle is 12 weeks minimum) ]

Secondary Outcome Measures :
  1. Mean change from Baseline to each post-treatment visit in the vaginal pain as reported on the 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  2. Proportion of subjects who reported at least a 30% decrease in vaginal pain as reported on the 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) at each post-treatment visit - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  3. Proportion of subjects who reported at least 2-point decrease in vaginal pain as reported on the 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) at each post baseline visit - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  4. Mean change from Baseline to each post-treatment visit in maximum tolerated vaginal pain reported on 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  5. Mean change from Baseline to each post-treatment visit in the composite score of the vaginal pain - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  6. Mean change form Baseline to each post-treatment visit in the vaginal pain as reported on the 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  7. Mean change from Baseline to each post-treatment visit in the pain during intercourse as reported on the 11-point pain NRS (scoring 0-no pain to 10-worst possible pain) - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until the end of study (up to 52 weeks) ]
  8. Mean change from Baseline to each post-treatment visit in the number of intercourse instances in subjects with partners - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until the end of study (up to 52 weeks) ]
  9. Mean Clinical Global Impression (CGI) as assessed by the investigator of the treatment effect at each post-treatment visit - stage 1 and 2 [ Time Frame: Week 6, Week 12, and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) until end of study (up to 52 weeks) ]
  10. Mean score for Patient Global Impression of change in pain (PGI-C) as assessed by the subject at each post-treatment visit - stage 1 and 2 [ Time Frame: Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) up to 52 weeks ]
  11. Mean change from baseline for Patient Global Impression of severity of pain (PGI-S) as assessed by the subject at each visit - stage 1 and 2 [ Time Frame: Screening, Baseline, Week 6, Week 12 and then every 6 weeks (all treatment cycles, each cycle being 12 weeks minimum) up to 52 weeks ]
  12. Use of pain rescue medication (type, dose and frequency) - stage 1 and 2 [ Time Frame: Throughout the study (up to 52 weeks) ]

Other Outcome Measures:
  1. Incidence of treatment emergent AEs (TEAEs), serious AEs (SAEs), clinically significant AEs, DLEs, AEs (or SAEs) leading to discontinuations and AEs of special interest (AESIs). [ Time Frame: Throughout the study (up to 52 weeks) ]
  2. Number of subjects who seroconvert for Botulinum Toxin (BTX) antibodies following treatment with Dysport. [ Time Frame: Throughout the study (up to 52 weeks) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal
  • Have never had a vaginal delivery including attempted vaginal delivery
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598777


Contacts
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Contact: Ipsen Recruitment Enquiries clinical.trials@ipsen.com

Locations
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United States, California
Women's Health Care Research Not yet recruiting
San Diego, California, United States, 92111
San Diego Sexual Medicine Recruiting
San Diego, California, United States, 92120
United States, District of Columbia
James A. Simon, MD, PC Recruiting
Washington, District of Columbia, United States, 20036
The Center for Vulvovaginal Disorders Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Clinical Research Center of Florida Recruiting
Pompano Beach, Florida, United States, 33060
United States, Missouri
University of Kansas Medical Center Recruiting
Kansas City, Missouri, United States, 66160
United States, Nebraska
Omaha OB-GYN Associates, PC Recruiting
Omaha, Nebraska, United States, 68130
United States, New Jersey
The Center for Specialized Women's Health Recruiting
Denville, New Jersey, United States, 07834
Rutgers, Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
United States, New York
The Center for Vulvovaginal Disorders Recruiting
New York, New York, United States, 10036
The Arthur Smith Institute for Urology Recruiting
New York, New York, United States, 11040
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45044
University of Cincinnati - Center for Reproductive Health Not yet recruiting
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Center for Pelvic Medicine Terminated
Bryn Mawr, Pennsylvania, United States, 19010
United States, Tennessee
Women's Institute for Sexual Health (WISH) Recruiting
Nashville, Tennessee, United States, 37209
United States, Washington
Seattle Women's: Health, Research, Gynecology® Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Ipsen
Investigators
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Study Director: Ipsen Medical Director Ipsen

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Responsible Party: Ipsen
ClinicalTrials.gov Identifier: NCT03598777     History of Changes
Other Study ID Numbers: D-FR-52120-236
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: July 26, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vulvodynia
Vulvar Diseases
Genital Diseases, Female
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents