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Placebo-controlled RCT of Botulinum Toxin A as a Treatment for Provoked Vestibulodynia

NCT02773641 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-08-14

No results posted yet for this study

Summary

Women with provoked vestibulodynia (PVD) suffer from severe dyspareunia and often present a hyperactivity of the pelvic floor muscles (PFM) which maintain the dyspareunia. The rationale for the study is that for women with PVD who don't succeed to restore the function of the PFM by physiotherapy, Botulinum Toxin A (BTA) could be an optional treatment by decreasing the high muscle tonus and thus possibly reduce the coital pain.

Conditions

  • Vulvodynia

Interventions

DRUG

Botulinum Toxin Type A

DRUG

Sterile Saline Solution

Sponsors & Collaborators

Principal Investigators

  • Nina Bohm-Starke, MD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2019-06-30
Completion
2019-06-30

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT02773641 on ClinicalTrials.gov