IncobotulinumtoxinA for Vulvodynia

Recruiting at 1 trial location

Overseen By Andrew Goldstein, MD

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Center for Vulvovaginal Disorders

Must not be taking: Muscle relaxants, Steroid injections

Disqualifiers: Anterior vestibular pain, Genitourinary conditions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24-30 weeks

54 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a woman who is 18 years old or older.

* Willing to provide a written informed consent prior to any study related procedures.

* 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive incobotulinumtoxinA or placebo for the treatment of provoked vestibulodynia

24-30 weeks

Regular visits for treatment and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IncobotulinumtoxinA

How Is the Trial Designed?

Group I: INA group Experimental Treatment 1 Intervention

Group II: Placebo Group Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Center for Vulvovaginal Disorders

Lead Sponsor

Trials

8

Recruited

270+

Merz Pharmaceuticals

Industry Sponsor

Trials

6

Recruited

460+