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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UNKNOWN
PHASE4
64 participants
INTERVENTIONAL
2005-04-30
2008-06-30
Brief Summary
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Detailed Description
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The aetiology of VVS is not well established and many variables have been associated with the condition, e.g. neuropathy secondary to inflammation.
Injection of Botulinum Toxin is tested as a therapeutic option for this condition.
A temporary paralytic effect on the surrounding skeletal muscle hypertonicity is seen and earlier in cases described as a successful treatment of pelvic floor dysfunction, dyspareunia and interstitial cystitis.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Interventions
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Botulinum toxin
Eligibility Criteria
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Inclusion Criteria
* Safe birth control
Exclusion Criteria
* Ongoing vulvar infection
* Age\<18
* Skin disease
* Pregnancy
* Myasthenia gravis
* Amyotrophic lateral sclerosis (ALS)
* Diabetes
* Using:
* Calcium antagonists;
* Aminoglycosides;
* Magnesium sulfate;
* Systemic steroid treatment
18 Years
80 Years
FEMALE
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Principal Investigators
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Christina Damsted Petersen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Lene Lundvall
Role: CONTACT
Facility Contacts
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Lene Lundvall
Role: backup
Lene Lundvall
Role: backup
References
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Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40. doi: 10.1016/j.jpain.2004.02.575.
Related Links
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Related Info
Other Identifiers
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Bosex
Identifier Type: -
Identifier Source: org_study_id