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New treatment option for Provoked Vestibulodynia
Official title Topical Ketotifen 0.25% for Secondary Vestibulodynia
ClinicalTrials.gov ID: NCT07257029
What this study is testing
What is Ketotifen Fumarate 0.25% Cream?
Ketotifen Fumarate 0.25% Cream is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for provoked vestibulodynia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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...
- 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)
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Tampa, Florida, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Tampa, Florida, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.