Actively Recruiting
A Double Blind, Placebo Controlled Study of IncobotulinumtoxinA in Patients With Provoked Vestibulodynia Associated With Overactive Pelvic Floor Muscle Dysfunction
Led by Center for Vulvovaginal Disorders · Updated on 2026-03-23
54
Participants Needed
2
Research Sites
10 weeks
Total Duration
On this page
Sponsors
C
Center for Vulvovaginal Disorders
Lead Sponsor
M
Merz Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating incobotulinumtoxinA for treating provoked vestibulodynia (PVD) linked to overactive pelvic floor muscle dysfunction. This phase 2, double-blind, placebo-controlled study focuses on premenopausal females aged 18 years or older who have a confirmed diagnosis of PVD with hypertonic pelvic floor muscles. The study aims to assess the safety and effectiveness of this treatment compared to a placebo saline injection. Participants are randomly assigned to receive either incobotulinumtoxinA injections or placebo saline injections into the pelvic floor muscles. The study includes treatment and follow-up periods lasting up to 24 to 30 weeks, during which participants undergo pain assessments using dilator testing. The study evaluates changes in pain levels and the Patient Global Impression of Change (PGI-C). During the study, participants attend clinic visits for pain testing and physical evaluations, including cotton swab testing and dilator testing at baseline and final visits. Researchers monitor pain scores, treatment effects, and any side effects. Participants must comply with study restrictions and return for follow-up assessments. The primary outcome is the maximum dilator size tolerated at baseline and at the final visit around 24 to 30 weeks after treatment.
CONDITIONS
Brief Title
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years or older
- Premenopausal
- Willing to provide written informed consent before study procedures
- Diagnosed with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for 3 months to 15 years
- Bilateral provoked pain at the posterior vestibule on cotton swab test at baseline
- Diagnosis confirmed by both an expert physician and pelvic floor physical therapist
- Able to tolerate smallest dilator size (0.5 inches) and agree to pain testing with next dilator size
- Pain score of 5 or greater on 11-point Numeric Rating Scale during dilator testing at baseline
- Willing and able to comply with study requirements and attend all visits
- Stable dose of oral antidepressants, anxiolytics, or anti-epileptics for at least 3 months if used
- Stable frequency of pelvic floor physical therapy for at least 8 weeks if currently undergoing therapy
- If vaginal/vulvar infections present at baseline, willing to undergo prescribed treatment
You will not qualify if you...
- Provoked pain on cotton swab test at anterior vestibule at baseline
- Able to tolerate 6th dilator size (1 1/4 inches) with pain score less than 5 at baseline
- Genitourinary or gastrointestinal conditions interfering with treatment or assessments, including skin diseases like lichen sclerosus or planus
- Severe endometriosis requiring regular non-hormonal medications
- Pudendal neuralgia with significant tenderness
- Genitourinary or rectal cancer
- Congenital urogenital abnormalities
- Pain in urethra
- Symptomatic urogenital prolapse
- History of traumatic or post-radiotherapy vulvar lesions
- Previous surgeries impacting study outcomes, including vaginal hysterectomy or vestibulectomy
- Current vaginal/vulvar infections unwilling or unable to treat
- Significant alcohol or drug abuse or dependence
- Changes in pelvic floor physical therapy within 8 weeks prior to baseline
- Muscle relaxant use in past 2 weeks
- Hormonal cream treatment for anterior vestibular pain within 1 week prior unless stable
- Treatment for urinary incontinence currently ongoing
- Steroid injections in vulva within 4 weeks prior or planned during study
- Botulinum toxin injection in genitopelvic area within past 12 months
- Use of investigational drugs within 4 weeks prior or planned during study
- Likely need for prohibited medications during study
- Mental condition preventing understanding or cooperation
- Pregnant, planning pregnancy, or breastfeeding
- Not using acceptable birth control methods if sexually active with male partner during study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 to 30 weeks
Participants receive incobotulinumtoxinA or placebo injections into pelvic floor muscles to treat provoked vestibulodynia with overactive pelvic floor muscle dysfunction.
Multiple visits for injections and assessments during treatment period
Trial Site Locations
Total: 2 locations
1
Center for VulvoVaginal Disorders
Washington D.C., District of Columbia, United States, 21012
Actively Recruiting
2
Centers for Vulvovaginal Disorders, NY
New York, New York, United States, 10036
Actively Recruiting
Research Team
A
Andrew Goldstein, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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