search
Back to results

A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia (CAPSIVU)

Primary Purpose

Vestibulodynia

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Capsaicin patch
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vestibulodynia focused on measuring capsaicin, pain improvement, provoked vulvodynia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Besançon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Capsaicin patch

Arm Description

Cuttable capsaicin patch. 2 patches of 4 cm² (2 x 2cm), for a total of 2.5 mg of capsaicin.

Outcomes

Primary Outcome Measures

Pain assessment with Visual Analogic Scale (using a q-tip)
Assessment of provoked pain with Visual Analogic Scale (using a q-tip)

Secondary Outcome Measures

Full Information

First Posted
August 1, 2016
Last Updated
November 9, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
search

1. Study Identification

Unique Protocol Identification Number
NCT02854670
Brief Title
A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
Acronym
CAPSIVU
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
January 20, 2016 (Actual)
Primary Completion Date
February 3, 2021 (Actual)
Study Completion Date
February 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibulodynia
Keywords
capsaicin, pain improvement, provoked vulvodynia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capsaicin patch
Arm Type
Experimental
Arm Description
Cuttable capsaicin patch. 2 patches of 4 cm² (2 x 2cm), for a total of 2.5 mg of capsaicin.
Intervention Type
Drug
Intervention Name(s)
Capsaicin patch
Intervention Description
After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.
Primary Outcome Measure Information:
Title
Pain assessment with Visual Analogic Scale (using a q-tip)
Description
Assessment of provoked pain with Visual Analogic Scale (using a q-tip)
Time Frame
week 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabien Pelletier, MD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs