Overview

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

Status:
Unknown status
Trial end date:
2018-07-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Besancon
Treatments:
Capsaicin
Criteria
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