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

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ClinicalTrials.gov Identifier: NCT02858219
Recruitment Status : Recruiting
First Posted : August 8, 2016
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

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.

Condition or disease Intervention/treatment Phase
Vestibulodynia Drug: Botulinum Toxin Type A Other: Saline solution Other: Indexes Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Actual Study Start Date : May 4, 2010
Estimated Primary Completion Date : May 4, 2019
Estimated Study Completion Date : May 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Botulinum toxin

Injection of 50 units (50U) botulinum toxin type A (powder), reconstituted in 1 mL physiologic saline solution in each perineal muscle (100 units in total).

First injection at day 1 and. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).

Drug: Botulinum Toxin Type A
Other: Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)

Placebo Comparator: Saline solution
Injection of 1 mL physiologic saline solution in each perineal muscle. A second injection is scheduled at 3 months, only if there is a 50% or more pain improvement compared to baseline (pain measured with Visual Analogic Scale).
Other: Saline solution
Other: Indexes
Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02858219


Contacts
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Contact: Fabien Pelletier, MD fabien.pelletier@univ-fcomte.fr

Locations
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France
CHU Besançon Recruiting
Besançon, France, 25000
Contact: Fabien Pelletier, MD       fabien.pelletier@univ-fcomte.fr   
Hôpital Tenon Recruiting
Paris, France, 75020
Contact: Frédérique Lebreton, MD       frederique.lebreton@tnn.aphp.fr   
Principal Investigator: Gérard Amarenco, MD PhD         
Sub-Investigator: Frédérique Lebreton, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
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Principal Investigator: Fabien Pelletier, MD Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT02858219     History of Changes
Other Study ID Numbers: API/2011/20
First Posted: August 8, 2016    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Besancon:
Botulinum toxin
Pain improvement

Additional relevant MeSH terms:
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Vulvodynia
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Vulvitis
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents