MedTrace Logo

IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction

NCT07486830 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-03-23

No results posted yet for this study

Summary

This is a double-blind, placebo-controlled study evaluating the safety and efficacy of incobotulinumtoxinA (Merz) for the treatment of provoked vestibulodynia (PVD) associated with overactive pelvic floor muscle dysfunction. Eligible participants are premenopausal females aged 18 years and older with a confirmed diagnosis of PVD with hypertonic pelvic floor muscles, established by both an expert physician and an expert pelvic floor physical therapist. Participants must have bilateral provoked pain at the posterior vestibule on cotton swab testing and a pain score of 5 or greater on an 11-point Numeric Rating Scale (NRS) during standardized dilator testing at baseline. Key outcome measures include change in pain during dilator testing and Patient Global Impression of Change (PGI-C). Participants with anterior vestibular pain, prior botulinum toxin injection in the genitopelvic area within the past 12 months, or significant genitourinary conditions that may confound assessment are excluded.

Conditions

  • Provoked Vestibulodynia

Interventions

DRUG

Incobotulinum Toxin A

injections into pelvic floor muscles

DRUG

Placebo

placebo saline injection into pelvic floor muscles

Sponsors & Collaborators

  • Merz Pharmaceuticals

    collaborator INDUSTRY

  • Center for Vulvovaginal Disorders

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-27
Primary Completion
2026-12-20
Completion
2027-03-03
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT07486830 on ClinicalTrials.gov