A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia (NCT02858219) | Clinical Trial Compass
CompletedPhase 3
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
France60 participantsStarted 2010-05-04
Plain-language summary
The main objective of this study is to compare the efficacy of botulinum toxin injections on vestibulodynia pain compared to a group treated with a placebo.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
See this in plain English?
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Inclusion Criteria:
* Subject refractory to conventional treatments (tricyclic antidepressants and benzodiazepines at analgesic doses, biofeedback physical therapy)
* Negative screening test results
* Notified associated factors
* 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
* Myasthenia
* Treatment with aminoglycosides
* Major mental disorders
* Underlying etiology
* Vulnerable subjects (particularly adults under guardianship)
* Any reason deemed relevant by the investigator
* Current or former (in the last 3 months) participation to another clinical trial
What they're measuring
1
Pain improvement
Timeframe: 3 months
Trial details
NCT IDNCT02858219
SponsorCentre Hospitalier Universitaire de Besancon