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| Sponsored by: |
Rigshospitalet, Denmark |
|---|---|
| Information provided by: | Rigshospitalet, Denmark |
| ClinicalTrials.gov Identifier: | NCT00119886 |
Purpose
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
| Estimated Enrollment: | 64 |
| Study Start Date: | April 2005 |
| Estimated Study Completion Date: | June 2008 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Using:
Contacts and Locations| 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 |
| 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 | |
| Principal Investigator: | Christina Damsted Petersen, MD | Rigshospitalet, Denmark |
More Information
| Study ID Numbers: | Bosex |
| Study First Received: | July 6, 2005 |
| Last Updated: | April 18, 2007 |
| ClinicalTrials.gov Identifier: | NCT00119886 History of Changes |
| Health Authority: | Denmark: Danish Medicines Agency |
|
Genital Diseases, Female Botulinum Toxins Vulvar Vestibulitis |
Vulvar Vestibulitis Syndrome Botulinum Toxin Type A Vulvar Diseases |
|
Genital Diseases, Female Botulinum Toxins Anti-Dyskinesia Agents Vulvar Vestibulitis Therapeutic Uses |
Vulvitis Central Nervous System Agents Vulvar Diseases Pharmacologic Actions |
