NCT00119886

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2005

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2005

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 19, 2007

Status Verified

April 1, 2007

First QC Date

July 6, 2005

Last Update Submit

April 18, 2007

Conditions

Vulvar VestibulitisVulvar Diseases

Outcome Measures

Primary Outcomes (1)

  • Reduce vulvar pain on a visual analogue scale (VAS).

Secondary Outcomes (1)

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

Interventions

Botulinum toxinDRUG

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Vulvar vestibulitis
  • Safe birth control

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 15162347RESULT

Related Links

MeSH Terms

Conditions

Vulvar VestibulitisVulvar Diseases

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

VulvitisGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

MetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Christina Damsted Petersen, MD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina Damsted Petersen

CONTACT

+45 35 45 74 11rh19386@rh.dk

Lene Lundvall

CONTACT

+35 45 35 45

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2005

First Posted

July 14, 2005

Study Start

April 1, 2005

Study Completion

June 1, 2008

Last Updated

April 19, 2007

Record last verified: 2007-04

Locations

DK(2)