IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction

NCT07486830 | Recruiting Phase 2 FDA Drug

• 1 other identifier: CCVD-INA-PVD-001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Dilator Maximum Tested Size

  maximum dilator size tolerated

  baseline, week 24-30 (final visit)

Study Arms (2)

INA group

EXPERIMENTAL

Drug: Incobotulinum Toxin A

Placebo Group

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Incobotulinum Toxin A DRUG

injections into pelvic floor muscles

INA group

Placebo DRUG

placebo saline injection into pelvic floor muscles

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, 18 years or older.
• Willing to provide a written informed consent prior to any study related procedures.
• Premenopausal.
• Have vulvodynia with provoked vestibulodynia with overactive pelvic floor muscle dysfunction for at least 3 months duration and for no more than 15 years.
• Have provoked pain at the posterior vestibule on a cotton swab test, with pain at positions 4, 6 and 8 o'clock (must be bilateral pain) at the Baseline Visit.
• Have independently confirmed diagnoses of provoked vestibulodynia PVD with overactive pelvic floor muscle dysfunction (hypertonic pelvic floor muscles) confirmed by both an expert physician and expert pelvic floor physical therapist.
• Are able to tolerate the smallest dilator size (diameter 0.5 inches) at the Baseline Visit, i.e. agree to the next successive dilator size to be tested for pain response (i.e. the two smallest sized dilators (#1 and 2) are to be tested).
• Pain score ≥5 on an 11-point Numeric Rating Scale (NRS) for the Dilator Maximum Tested Size (DMTS) at the Baseline Visit.
• Willing and able to comply with study restrictions, able to attend the clinic for the required duration of assessments during the study period and willing to return to the clinic for the follow-up evaluation as specified in the protocol.
• If the subject has received oral antidepressants, anxiolytics or anti-epileptics, then the dose of these medications should have been stable for at least 3 months prior to the Baseline Visit and expected to remain stable throughout the study.
• If the subject is currently undergoing pelvic floor physical therapy then the frequency of visits should be stable for at least 8 weeks prior to the Baseline visit and expected to remain stable throughout the study.
• If the subject has vaginal/vulvar infections (bacterial vaginosis, presence of candidiasis or trichomoniasis) at Baseline Visit (provider will take a vaginal culture swab to test for infection), they may still participate as long as they undergo treatment for the infection (as prescribed by study provider).

You may not qualify if:

• Have provoked pain on a cotton swab test at the anterior vestibule (anywhere between 9 and 3 o'clock or more anteriorly) at the Baseline Visit.
• Able to tolerate the 6th (diameter 1 1⁄4 inches) dilator size (i.e. agree to the next successive dilator size to be tested for pain response) at the Baseline Visit with a pain score less than 5 (i.e. blue dilator).
• Genitourinary or gastrointestinal conditions/history which, according to the investigator's judgment may interfere with treatment or impact outcome assessment, including but not limited to:
• Skin disease at the vestibule such as lichen sclerosus, lichen planus, vaginal or vulvar atrophy, desquamative inflammatory vaginitis, allergic vulvitis, etc.
• Severe endometriosis (as defined as requiring regular medications other than hormonal contraceptives and NSAIDS to manage the endometriosis symptoms).
• Pudendal neuralgia (as defined as greater than minimal tenderness to palpation of the pudendal nerves at the ischial spine).
• Genitourinary or rectal cancer.
• Congenital urogenital abnormalities (e.g. vaginal septa, imperforate hymen, urethral diverticulum).
• Pain in urethra (diagnosis based on subject's interview and physical examination).
• Symptomatic urogenital prolapse at physical examination.
• History of traumatic or post radiotherapy vulvar lesions.
• Previous surgery that according to the investigator's judgment may impact on study outcome including but not limited to vaginal hysterectomy, vestibulectomy, urolxogic surgery (slings, colporrhaphy, etc.), perianal surgery or genital trauma or mutilation/cutting.
• Current vaginal/vulvar infections (bacterial vaginosis, candidiasis, or trichomoniasis) and are unwilling or unable to take oral medication to treat this infection.
• Clinically significant history of alcohol/drug abuse the last 24 weeks prior to Baseline or clinically significant alcohol/drug dependence within 2 years prior to Baseline. Exceptions include caffeine or nicotine abuse/dependence.
• Has received any of the following:

Sponsors & Collaborators

• Merz Pharmaceuticals: collaborator
• Center for Vulvovaginal Disorders: lead

Study Sites (2)

Center for VulvoVaginal Disorders

Washington D.C., District of Columbia, 21012, United States

RECRUITING

Centers for Vulvovaginal Disorders, NY

New York, New York, 10036, United States

RECRUITING

Central Study Contacts

Andrew Goldstein, MD

CONTACT

202-887-0568; obstetrics@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 23, 2026
• Study Start: February 27, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): March 3, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (2)