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Botox on Vulvar Vestibulitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: July 6, 2005
Last updated: April 18, 2007
Last verified: April 2007
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
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

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.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00119886

Contact: Christina Damsted Petersen +45 35 45 74 11 ext 85 89
Contact: Lene Lundvall +35 45 35 45 ext 50 31

Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Christina Damsted Petersen    +45 35 45 74 11 ext 85 89   
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   
Contact: Lene Lundvall    +35 45 35 45 ext 5031      
Principal Investigator: Christina Damsted Petersen         
Sponsors and Collaborators
Rigshospitalet, Denmark
Principal Investigator: Christina Damsted Petersen, MD Rigshospitalet, Denmark
  More Information

Additional Information:
Publications: Identifier: NCT00119886     History of Changes
Other Study ID Numbers: Bosex
Study First Received: July 6, 2005
Last Updated: April 18, 2007

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 25, 2017