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NCT07257029 · ClinicalTrials.gov registry record · Phase 2
Topical Ketotifen 0.25% for Secondary Vestibulodynia
A Phase 2 study of Vulvodynia and Provoked Vestibulodynia, sponsored by Center for Vulvovaginal Disorders.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 54
- Enrollment target
- 3
- Study locations
NCT07257029 is a Phase 2 study of Vulvodynia and Provoked Vestibulodynia that is actively recruiting participants, run by Center for Vulvovaginal Disorders. The registered enrollment target is 54 participants, below the 132-participant average among 9 other Vulvodynia trials with a reported enrollment target (59% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT07257029, a Phase 2 study of Vulvodynia and Provoked Vestibulodynia, is actively recruiting participants, sponsored by Center for Vulvovaginal Disorders.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 54 participants
- Enrollment target
- 3
- Study locations
Study Summary
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, often following recurrent infections or topical irritant exposures. Preclinical studies suggest that ketotifen, a mast-cell stabilizer and histamine H1 antagonist, may reduce neuroinflammation and abnormal nerve growth in the vulvar vestibule, offering a mechanism-based, non-surgical treatment option. Approximately 54 women aged 18 years and older who meet ISSVD/ISSWSH/IPPS criteria for secondary PVD without vulvovaginal atrophy will be enrolled. After a 1-week screening period, all participants will complete a 2-week single-blind placebo run-in; those with a strong placebo response or intolerance to vehicle cream will not be randomized. Eligible participants will then be randomized 1:1 to receive ketotifen fumarate 0.25% cream or matching placebo cream applied twice daily to the vulvar vestibule for 12 weeks. The primary outcome is change from baseline to Week 15 in pain intensity with the baseline dilator maximum tested size (DMTS), measured on an 11-point numeric rating scale. Secondary outcomes include changes in Vulvodynia Experience Questionnaire (VEQ) scores, vestibular pain thresholds measured by Wagner algometry, and participant-reported meaningful benefit at the end of treatment. Safety assessments will include adverse events, application-site reactions, physical examinations, vital signs, and pregnancy testing. This study will provide the first controlled clinical data on topical ketotifen for secondary PVD and inform the feasibility of larger registration trials.
Conditions Studied
Interventions
- DRUG Ketotifen Fumarate 0.25% Cream
- DRUG Placebo (Vehicle Cream)
Study Locations (3)
District of Columbia
- The Center for Vulvovaginal Disorders - Washington, DC - Washington D.C.
Florida
- The Center for Vulvovaginal Disorders - Tampa
New York
- The Center for Vulvovaginal Disorders - New York - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2026-01-02 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07257029
The ClinicalTrials.gov registry entry for NCT07257029 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, below the 132-participant average among 9 other Vulvodynia trials with a reported enrollment target (59% lower). The listed sponsor is Center for Vulvovaginal Disorders, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Vulvodynia appearing as the primary indexed condition, and to 2 interventions - of which Ketotifen Fumarate 0.25% Cream is the first listed.
NCT07257029 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT07257029 about?
NCT07257029 is a clinical study titled "Topical Ketotifen 0.25% for Secondary Vestibulodynia". 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 s...
What is the current status of trial NCT07257029?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2026-01-02. Estimated completion is 2027-01-01.
What conditions does trial NCT07257029 study?
This clinical trial studies the following conditions: Vulvodynia, Provoked Vestibulodynia, Secondary Provoked Vestibulodynia, Vulvary Pain Disorders, Neuroproliferative Vestibulodynia.
What interventions are being tested in trial NCT07257029?
The interventions under investigation include: Ketotifen Fumarate 0.25% Cream (DRUG), Placebo (Vehicle Cream) (DRUG).
Who is sponsoring clinical trial NCT07257029?
This trial is sponsored by Center for Vulvovaginal Disorders, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07257029 being conducted?
This trial has 3 study locations across District of Columbia, Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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