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Botox on Vulvar Vestibulitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00119886
First received: July 6, 2005
Last updated: April 18, 2007
Last verified: April 2007
History of Changes
  Purpose

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 painkillers, and improving the sexual quality of life of the patients.


Condition Intervention Phase
Vulvar Vestibulitis
Vulvar Diseases
 Drug: Botulinum toxin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Reduce vulvar pain on a visual analogue scale (VAS).

Secondary Outcome Measures:
  • Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics

Estimated Enrollment: 64
Study Start Date: April 2005
Estimated Study Completion Date: June 2008
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 clinical findings.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Vulvar vestibulitis
  • Safe birth control

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119886

Contacts
Contact: Christina Damsted Petersen +45 35 45 74 11 ext 85 89 rh19386@rh.dk
Contact: Lene Lundvall +35 45 35 45 ext 50 31

Locations
Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Christina Damsted Petersen     +45 35 45 74 11 ext 85 89     rh19386@rh.dk    
Contact: Lene Lundvall     +45 35 45 35 ext 5031        
Principal Investigator: Christina Damsted Petersen            
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Christina Damsted Petersen, MD     +35 45 35 45 ext 8589     rh19386@rh.dk    
Contact: Lene Lundvall     +35 45 35 45 ext 5031        
Principal Investigator: Christina Damsted Petersen            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Christina Damsted Petersen, MD Rigshospitalet, Denmark
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00119886     History of Changes
Other Study ID Numbers: Bosex
Study First Received: July 6, 2005
Last Updated: April 18, 2007
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Vulvar Diseases
Vulvar Vestibulitis
Genital Diseases, Female
Vulvitis
Botulinum Toxins
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013