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Trial record 19 of 40 for:    "Vulvar Vestibulitis Syndrome"

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

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.

Condition or disease Intervention/treatment Phase
Vulvar Vestibulitis Vulvar Diseases Drug: Botulinum toxin Phase 4

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 : Interventional  (Clinical Trial)
Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : April 2005
Estimated Study Completion Date : June 2008

Resource links provided by the National Library of Medicine





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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications of Results:
ClinicalTrials.gov Identifier: NCT00119886     History of Changes
Other Study ID Numbers: Bosex
First Posted: July 14, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvar Diseases
Vulvitis
Genital Diseases, Female
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs