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NCT02858219 Clinical Trial

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

Vestibulodynia Clinical Trial

— VESTIBULE  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02858219
Other study ID # API/2011/20
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 4, 2010
Est. completion date February 11, 2019

Study information
Verified date November 2022
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 11, 2019
Est. primary completion date February 11, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Botulinum Toxin Type A

Other:
• Saline solution

• Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)

Locations
Country Name City State
France CHU Besançon Besançon
France Hôpital Tenon Paris

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain improvement Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale 3 months
See also
  Status Clinical Trial Phase
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Completed NCT01455350 - Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia N/A
Completed NCT01304589 - Savella in Treatment for Provoked Vestibulodynia Phase 3
Active, not recruiting NCT03844412 - Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments Phase 2
Completed NCT01582373 - Pilot Study to Assess the Efficacy of Cognitive-behavioral Couple Therapy for Provoked Vestibulodynia N/A
Completed NCT05342402 - Feasibility Study for Provoked Vestibulodynia N/A
Recruiting NCT05805696 - Treatment and Mapping of Impostor Phenomenon N/A
Completed NCT01935063 - Study to Compare the Efficacy of Cognitive-behavioral Couple Therapy and Lidocaine for Provoked Vestibulodynia N/A
Completed NCT02204319 - Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief N/A
Completed NCT02858375 - Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia N/A
Completed NCT02362763 - The Use of Acupuncture for the Treatment of Vulvar Vestibulitis N/A
Withdrawn NCT01741948 - Hormonal Contraceptive Use and the Risk of Provoked Vestibulodynia N/A
Terminated NCT02854670 - A Study of the Effects of Topical Capsaicin in the Treatment of Provoked Vestibulodynia Phase 2/Phase 3
Recruiting NCT04613713 - Somatocognitive Therapy in Treatment of Provoked (Localized) Vestibulodynia - Randomized Clinical Trial (ProLoVe Study) N/A
Terminated NCT01295268 - Study of Emu Oil vs. Placebo for Vulvar Pain in Women. N/A
Terminated NCT03682601 - Sexual Penetration Pain in Postmenopausal Women: A Topical Botanical Drug Treatment Phase 2
Withdrawn NCT03390049 - Randomized CO2 vs Sham Laser Treatment of Provoked Vestibulodynia N/A
Completed NCT00496184 - Efficacy Study of Topical Application of Nifedipine Cream to Treat Vulvar Vestibulitis Phase 3
Completed NCT03431779 - Lipofilling as a Treatment for Vestibulodynia N/A