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Botox on Vulvar Vestibulitis

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ClinicalTrials.gov Identifier: NCT00119886
Recruitment Status : Unknown
Verified April 2007 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : July 14, 2005
Last Update Posted : April 19, 2007
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Tracking Information
First Submitted Date  ICMJE July 6, 2005
First Posted Date  ICMJE July 14, 2005
Last Update Posted Date April 19, 2007
Study Start Date  ICMJE April 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
Reduce vulvar pain on a visual analogue scale (VAS).
Original Primary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
Reduce vulvar pain on a VAS scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2006)
Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics
Original Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2005)
Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgetics
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botox on Vulvar Vestibulitis
Official Title  ICMJE Not Provided
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 painkillers, and improving the sexual quality of life of the patients.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Vulvar Vestibulitis
  • Vulvar Diseases
Intervention  ICMJE Drug: Botulinum toxin
Study Arms  ICMJE Not Provided
Publications * Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: April 18, 2007)
64
Original Enrollment  ICMJE
 (submitted: July 6, 2005)
65
Estimated Study Completion Date  ICMJE June 2008
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00119886
Other Study ID Numbers  ICMJE Bosex
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Rigshospitalet, Denmark
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christina Damsted Petersen, MD Rigshospitalet, Denmark
PRS Account Rigshospitalet, Denmark
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP