Topical ketotifen 0.25% for secondary vestibulodynia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, multicenter, randomized, double-blind, placebo-controlled trial compares topical ketotifen 0.25% cream to a matching vehicle in adult women with secondary provoked vestibulodynia. Approximately 54 participants will complete a screening and a 2-week single-blind placebo run-in, and eligible non–placebo-responders will be randomized with blinded outcome assessment. The drug is a mast-cell stabilizer and H1 antagonist intended to reduce local neuroinflammation and pathological nerve proliferation in the vestibular mucosa. Safety, pain reduction, and function-related outcomes will be measured across study visits at participating centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female participants ≥18 years of age
* Able to provide signed and dated informed consent
* Able to read, write, understand, and complete English-language study-related forms and communicate in English
* Has a stable address and is available for the duration of the study
* In good general health based on medical history
* Willing to comply with all study procedures
* Body mass index (BMI) between 18.5 kg/m² and 32.0 kg/m² (inclusive)
* Meets ISSVD/ISSWSH/IPPS criteria for secondary provoked vestibulodynia, including: 6 continuous months of vulvar symptoms (insertional dyspareunia, pain with tampon insertion, or pain to touch); moderate to severe vestibular tenderness to light touch on physical exam
* No evidence of vulvovaginal atrophy
* If atrophy is present, must complete ≥12 weeks of topical hormone therapy and be re-screened to confirm resolution before enrollment
* Negative vaginal culture for infection at randomization (participants with positive cultures at screening may be treated and retested)

Exclusion Criteria:

* Pregnancy or lactation
* Unable to tolerate the smallest dilator during baseline dilator assessment
* Active vaginal infection (Candida, BV, trichomonas, HSV)
* May re-screen after treatment and documented cure
* Active cutaneous disease of the vestibule
* Current presentation of other painful vulvar conditions, including:

Pudendal neuralgia Lichen sclerosus Lichen planus Plasma cell vulvitis Vulvar intraepithelial neoplasia Sjögren's disease Desquamative inflammatory vaginitis

* Hypoestrogenic states (e.g., vulvar atrophy due to menopause or medications)
* History of significant vestibular or vaginal surgery, including:

Vestibulectomy Perineoplasty Bladder neck suspension Anterior/posterior colporrhaphy Pudendal nerve neurolysis Ablative or fractional laser procedures

* Initiation or planned change in any of the following within 30 days before screening or during the study:

Gabapentinoids Tricyclic antidepressants SSRIs or SNRIs Hormone replacement therapy Systemic or local muscle relaxants (benzodiazepines, baclofen, botulinum toxin, cyclobenzaprine, CBD suppositories) Pelvic floor physical therapy

* Use of another investigational drug or intervention within the past 3 months
* Positive vaginal culture during the study requiring two or more treatments (per protocol, second infection leads to termination)
* Any condition or factor that, in the opinion of the investigator, would interfere with study participation or safety

Where it's running

• The Center for Vulvovaginal Disorders - Washington, DC
  Washington D.C., District of Columbia, United States Recruiting
• The Center for Vulvovaginal Disorders
  Tampa, Florida, United States Recruiting
• The Center for Vulvovaginal Disorders - New York
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Andrew T Goldstein, MD — Center for Vulvovaginal Disorders
• Study coordinator: Andrew T Goldstein, MD
• Email: obstetrics@yahoo.com
• Phone: 410-279-0209

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IncobotulinumtoxinA (botulinum toxin) injections for provoked vestibulodynia with overactive pelvic floor muscles

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• 12-week online pelvic health program for provoked vestibulodynia

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• Improving diagnosis of vestibulodynia using omics approaches

  This study is trying to find better ways to diagnose vestibulodynia in women aged 18 to 50 by looking at biological samples to see if there are specific markers that can help identify this painful condition.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.