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.
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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…
Contacts

Andrew T Goldstein, MD

410-279-0209

obstetrics@yahoo.com

CONTACT

Kate L Tolleson, MS

903-424-1410

kate@vulvodynia.com

CONTACT