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

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.

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Key information

Conditions

Vestibulodynia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vulvar Diseases Vulvodynia

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

CHU Besançon, Besançon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum Toxin Type A

Drug

Saline solution

Other

Indexes

Other

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

Primary outcomes

Pain improvement

Time frame: 3 months

Significant improvement of pain on contact in the treated group, compared to placebo group, measured with Visual Analogic Scale

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: VESTIBULE

Important dates

Study start: 2010
Primary completion: 2019
Study completion: 2019
First posted: Aug 8, 2016
Registry last updated: Nov 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed