NCT02858219

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2010

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2010

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 8, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2019

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

8.8 years

First QC Date

August 1, 2016

Last Update Submit

November 9, 2022

Conditions

Vestibulodynia

Keywords

Botulinum toxinPain improvement

Outcome Measures

Primary Outcomes (1)

  • Pain improvement

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

    3 months

Study Arms (2)

Botulinum toxin

EXPERIMENTAL

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 AOther: Indexes

Saline solution

PLACEBO COMPARATOR

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 solutionOther: Indexes

Interventions

Botulinum Toxin Type ADRUG
Botulinum toxin
Saline solutionOTHER
Saline solution
IndexesOTHER

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

Botulinum toxinSaline solution

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Besançon

Besançon, 25000, France

Location

Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Vulvodynia

Interventions

Botulinum Toxins, Type ASaline Solution

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Fabien Pelletier, MD

    Centre Hospitalier Universitaire de Besancon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2016

First Posted

August 8, 2016

Study Start

May 4, 2010

Primary Completion

February 11, 2019

Study Completion

February 11, 2019

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)