Vulvar VestibulitisPhase 4NCT00119886
Botox on Vulvar Vestibulitis
A Phase 4 study testing Botulinum toxin in people with Vulvar Vestibulitis and Vulvar Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vulvar Vestibulitis, Vulvar Diseases
- What is being tested?
- Botulinum toxin
- How many people
- 64 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2005to Jun 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Vulvar vestibulitis
- Safe birth control
Who cannot join
- Treated earlier with Botulinum toxin
- Ongoing vulvar infection
- Age<18
- Skin disease
- Pregnancy
- Myasthenia gravis
Show all 13Show fewer
- Amyotrophic lateral sclerosis (ALS)
- Diabetes
- Using:
- Calcium antagonists;
- Aminoglycosides;
- Magnesium sulfate;
- Systemic steroid treatment
Trial locations and contacts
2 sites in 1 country.
Lene Lundvall contact
Denmark2 sites, 2 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Christina Damsted Petersen, +45 35 45 74 11 ext. 85 89, rh19386@rh.dk
Lene Lundvall, +45 35 45 35 ext. 5031
- Recruiting
Rigshospitalet
Copenhagen, 2100
Christina Damsted Petersen, MD, +35 45 35 45 ext. 8589, rh19386@rh.dk
Lene Lundvall, +35 45 35 45 ext. 5031
About this study
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.
Read the 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.
- Conditions
- Vulvar Vestibulitis, Vulvar Diseases
- Being tested
- Botulinum toxin
- Medical subject headings
- Vulvar Vestibulitis, Vulvar Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2005 (estimated)
- Study startApr 2005
- Study completionJun 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvar VestibulitisStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 64 participants
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Christina Damsted Petersen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00119886
- Sponsor's protocol ID
- Bosex
- Status last verified
- Apr 2007
- First submitted
- 6 Jul 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Publications
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.
PubMed 15162347
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Botox on Vulvar Vestibulitis
- ClinicalTrials.gov ID
- NCT00119886
- Acronym / sponsor ID
- Bosex
- Conditions
- Vulvar Vestibulitis, Vulvar Diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jun 2008 (estimated)
- First posted
- 14 Jul 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Vulvar vestibulitis
- Safe birth control
Key exclusion criteria (13 listed)
- Treated earlier with Botulinum toxin
- Ongoing vulvar infection
- Age<18
- Skin disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin | Drug | – |
Primary outcome
Reduce vulvar pain on a visual analogue scale (VAS).
1 secondary outcome
Investigate the effect on sexuality, quality of life, marital relationship, depression and need of analgesics
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
- Results publication: PubMed 15162347Gunter 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.
- Related InfoLink provided by the sponsor.
Related trials for Vulvar Vestibulitis
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Biomodulation and Rehabilitation Interventions to tarGet Pelvic Health
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IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
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Topical Ketotifen 0.25% for Secondary Vestibulodynia
Provoked Vestibulodynia, Secondary Provoked Vestibulodynia
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Does a Virtual Program for Pelvic Pain Improve Pain and Sexual Outcomes in Individuals With Provoked Vestibulodynia?
Vulvodynia (Chronic Vulvar Pain), Vulvar Vestibulitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Lundvall contact
Christina Damsted Petersen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botulinum toxin in people with Vulvar Vestibulitis and Vulvar Diseases, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christina Damsted Petersen (+45 35 45 74 11 ext. 85 89, rh19386@rh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduce vulvar pain on a visual analogue scale (VAS).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00119886, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.