Topical Ketotifen 0.25% for Secondary Vestibulodynia
Recruiting
Phase 2
Interventional Study
Provoked Vestibulodynia
Secondary Provoked Vestibulodynia
Vulvodynia
Vulvary Pain Disorders
Neuroproliferative Vestibulodynia
Mast Cell-mediated Neuroinflammation
Instertional Dyspareunia
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 54 (estimated)
- Sponsor
- Center for Vulvovaginal Disorders · Other
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About This Trial
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of topical ketotifen fumarate 0.25% cream in adult women with secondary provoked vestibulodynia (PVD). Secondary PVD is a chronic vulvar pain condition characterized by burning or sharp pain with vaginal penetration (e.g., intercourse, tampon use) and touch of the vulvar vestibule…
Trial Locations
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Eligibility Criteria
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 g…
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