Status:
UNKNOWN
Botox on Vulvar Vestibulitis
Lead Sponsor:
Rigshospitalet, Denmark
Conditions:
Vulvar Vestibulitis
Vulvar Diseases
Eligibility:
FEMALE
18-80 years
Phase:
PHASE4
Brief Summary
The study seeks to evaluate the effect of botulinum toxin on vulvar vestibulitis (VVS) after local injection with Botox, a potential treatment to relieve patients of vulvar pain, reducing the need for...
Detailed Description
Vulvar vestibulitis (VVS) is characterized by pain confined to the vulvar vestibule that occurs upon touch and attempted introitus entry ( e.g. intercourse, tampon insertion), with minimal associated ...
Eligibility Criteria
Inclusion
- Vulvar vestibulitis
- Safe birth control
Exclusion
- Treated earlier with Botulinum toxin
- Ongoing vulvar infection
- Age\<18
- Skin disease
- Pregnancy
- Myasthenia gravis
- Amyotrophic lateral sclerosis (ALS)
- Diabetes
- Using:
- Calcium antagonists;
- Aminoglycosides;
- Magnesium sulfate;
- Systemic steroid treatment
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
End Date :
June 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00119886
Start Date
April 1 2005
End Date
June 1 2008
Last Update
April 19 2007
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
Rigshospitalet
Copenhagen, Denmark, 2100