A Pilot Study of the Effects of Botulinum Toxin in the Treatment of Provoked Vestibulodynia

• Status: Unknown status
• Trial end date: 2019-05-04
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Universitaire de Besancon
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

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