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

NCT02858219 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-10

No results posted yet for this study

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.

Conditions

  • Vestibulodynia

Interventions

DRUG

Botulinum Toxin Type A

OTHER

Saline solution

OTHER

Indexes

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

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Besancon

    lead OTHER

Principal Investigators

  • Fabien Pelletier, MD · Centre Hospitalier Universitaire de Besancon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-04
Primary Completion
2019-02-11
Completion
2019-02-11

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02858219 on ClinicalTrials.gov