RecruitingInterventionalPhase 2Updated Mar 23, 2026
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia | NCT02858219 | Trialant
CompletedInterventionalPhase 3Updated Nov 10, 2022
A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia
ClinicalTrials.gov ID
NCT02858219
Lead Sponsor
Centre Hospitalier Universitaire de BesanconOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
60Actual
Last Update Posted
Nov 10, 2022Actual
Start Date
May 4, 2010Actual
Primary Completion Date
Feb 11, 2019Actual
Completion Date
Feb 11, 2019Actual
Brief 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.
Vestibulodynia
Botulinum Toxin Type A
Saline solution
Indexes
Ages Eligible for Study
Adult (18-64)
Sexes Eligible for Study
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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