A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia (NCT02854670) | Clinical Trial Compass
TerminatedPhase 2/3
A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia
Stopped: Recruitment difficulties
France10 participantsStarted 2016-01-20
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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/…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain assessment with Visual Analogic Scale (using a q-tip)
Timeframe: week 12
Trial details
NCT IDNCT02854670
SponsorCentre Hospitalier Universitaire de Besancon