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Botox on Vulvar Vestibulitis

Primary Purpose

Vulvar Vestibulitis, Vulvar Diseases

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Botulinum toxin
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvar Vestibulitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • RigshospitaletRecruiting
  • RigshospitaletRecruiting

Outcomes

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

Full Information

First Posted
July 6, 2005
Last Updated
April 18, 2007
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00119886
Brief Title
Botox on Vulvar Vestibulitis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Unknown status
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvar Vestibulitis, Vulvar Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
64 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Primary Outcome Measure Information:
Title
Reduce vulvar pain on a visual analogue scale (VAS).
Secondary Outcome Measure Information:
Title
Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christina Damsted Petersen
Phone
+45 35 45 74 11
Ext
85 89
Email
rh19386@rh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lene Lundvall
Phone
+35 45 35 45
Ext
50 31
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Damsted Petersen, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Damsted Petersen
Phone
+45 35 45 74 11
Ext
85 89
Email
rh19386@rh.dk
First Name & Middle Initial & Last Name & Degree
Lene Lundvall
Phone
+45 35 45 35
Ext
5031
First Name & Middle Initial & Last Name & Degree
Christina Damsted Petersen
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christina Damsted Petersen, MD
Phone
+35 45 35 45
Ext
8589
Email
rh19386@rh.dk
First Name & Middle Initial & Last Name & Degree
Lene Lundvall
Phone
+35 45 35 45
Ext
5031
First Name & Middle Initial & Last Name & Degree
Christina Damsted Petersen

12. IPD Sharing Statement

Citations:
PubMed Identifier
15162347
Citation
Gunter J, Brewer A, Tawfik O. Botulinum toxin a for vulvodynia: a case report. J Pain. 2004 May;5(4):238-40. doi: 10.1016/j.jpain.2004.02.575.
Results Reference
result
Links:
URL
http://www.nva.org/
Description
Related Info

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Botox on Vulvar Vestibulitis

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