A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
NCT ID: NCT02858219
Last Updated: 2022-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2010-05-04
2019-02-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum toxin
Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total).
First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
Botulinum Toxin Type A
Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Saline solution
Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
Saline solution
Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Interventions
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Botulinum Toxin Type A
Saline solution
Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
Eligibility Criteria
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Inclusion Criteria
* Negative screening test results
* Notified associated factors
* Menopause, surgically sterilized women or women using effective contraceptive method
* Good understanding and predictable adherence to the protocol
* beneficiary/affiliated to French social security/social healthcare
* signed Informed Consent Form
Exclusion Criteria
* Pregnant or breastfeeding women
* Myasthenia
* Treatment with aminoglycosides
* Major mental disorders
* Underlying etiology
* Vulnerable subjects (particularly adults under guardianship)
* Any reason deemed relevant by the investigator
* Current or former (in the last 3 months) participation to another clinical trial
18 Years
60 Years
FEMALE
No
Sponsors
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Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Fabien Pelletier, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Besancon
Locations
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CHU Besançon
Besançon, , France
Hôpital Tenon
Paris, , France
Countries
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Other Identifiers
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API/2011/20
Identifier Type: -
Identifier Source: org_study_id
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