A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia

Vestibulodynia Clinical Trial

— CAPSIVU  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02854670
• Other study ID #: P/2013/199
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: January 20, 2016
• Est. completion date: February 3, 2021

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the pain on contact in provoked vestibulodynia, measured with Visual Analogic Scale at week 0/week 2/week 6/week 12 after applying a patch of capsaicin.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 3, 2021
• Est. primary completion date: February 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provoked vulvodynia, rated B2a according to 2003 International Society for the Study of Vulvovaginal Disease (ISSVD) classification

• Pain = 4 on Visual Analogic Scale (VAS)

• Subject refractory to at least 2 conventional treatments (tricyclic antidepressants, anticonvulsants at analgesic doses , biofeedback physical therapy, psychological assessment in a context of chronic pain) or to botulinum toxin A

• If a former treatment with botulinum toxin A was performed: patient must be in treatment failure (= no decrease over 50% of the pain 3 months after initiation of the treatment)

• Negative screening test results

• Menopause, surgically sterilized women or women using effective contraceptive method

• Good understanding and predictable adherence to the protocol

• Beneficiary/affiliated to French social security/social healthcare

• Signed Informed Consent Form

Exclusion Criteria:

• Predictable poor adherence

• Pregnant or breastfeeding women

• Diabetes mellitus type 1 or type 2

• Major mental disorders

• Underlying etiology such as chronic vulvar disease

• Initial vulvar erythema

• Vulnerable subjects (particularly adults under guardianship)

• Ongoing medical treatment with tricyclic antidepressants or anticonvulsants at analgesic doses

Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines doses analgesics, physiotherapy type of biofeedback)

Good understanding and predictable adherence to the protocol beneficiary/affiliated to French social security/social healthcare signed Informed Consent Form

Related Conditions & MeSH terms

• Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Drug:
• Capsaicin patch
After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.

Locations

Country	Name	City	State
France	CHU Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment with Visual Analogic Scale (using a q-tip)	Assessment of provoked pain with Visual Analogic Scale (using a q-tip)	week 12