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NCT07486830 · ClinicalTrials.gov registry record · Phase 2
IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction
A Phase 2 study of Provoked Vestibulodynia, sponsored by Center for Vulvovaginal Disorders.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 2
- Study locations
NCT07486830 is a Phase 2 study of Provoked Vestibulodynia that is actively recruiting participants, run by Center for Vulvovaginal Disorders. The registered enrollment target is 54 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT07486830, a Phase 2 study of Provoked Vestibulodynia, is actively recruiting participants, sponsored by Center for Vulvovaginal Disorders.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 2
- Study locations
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 Studied
Interventions
- DRUG Placebo
- DRUG Incobotulinum Toxin A
Study Locations (2)
District of Columbia
- Center for VulvoVaginal Disorders - Washington D.C.
New York
- Centers for Vulvovaginal Disorders, NY - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2026-02-27 |
| Est. Completion | 2027-03-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07486830
The ClinicalTrials.gov registry entry for NCT07486830 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Center for Vulvovaginal Disorders, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Provoked Vestibulodynia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07486830 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, New York.
Frequently Asked Questions
What is clinical trial NCT07486830 about?
NCT07486830 is a clinical study titled "IncobotulinumtoxinA for Provoked Vestibulodynia With Overactive Pelvic Floor Muscle Dysfunction". 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 wit...
What is the current status of trial NCT07486830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2026-02-27. Estimated completion is 2027-03-03.
What conditions does trial NCT07486830 study?
This clinical trial studies the following conditions: Provoked Vestibulodynia.
What interventions are being tested in trial NCT07486830?
The interventions under investigation include: Placebo (DRUG), Incobotulinum Toxin A (DRUG).
Who is sponsoring clinical trial NCT07486830?
This trial is sponsored by Center for Vulvovaginal Disorders, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07486830 being conducted?
This trial has 2 study locations across District of Columbia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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