Could a simple cream ease chronic pelvic pain?
NCT ID NCT07257029
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a cream called ketotifen fumarate for women who experience sharp or burning pain during vaginal penetration, a condition known as secondary vestibulodynia. About 54 women will apply the cream or a placebo to the painful area twice daily for 12 weeks. Researchers will measure changes in pain levels and quality of life to see if the cream helps.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ketotifen fumarate 0.25% cream
- What this could lead to
- If it works, this could offer a non-surgical, topical treatment to reduce pain during intercourse for women with secondary vestibulodynia.
- What could go wrong
- This is an early Phase 2 trial with only 54 participants. The cream may not reduce pain better than placebo, and results may not apply to all women with the condition.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Center for Vulvovaginal Disorders
RECRUITINGTampa, Florida, 33609, United States
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The Center for Vulvovaginal Disorders - New York
RECRUITINGNew York, New York, 10036, United States
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The Center for Vulvovaginal Disorders - Washington, DC
RECRUITINGWashington D.C., District of Columbia, 20037, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can needles quiet chronic pelvic pain?
- Can a laser beam silence chronic vulvar pain?
- A new approach to vulvar pain: could education and behavior change bring relief?
- Could a laser ease painful sex for millions of women?
- Can a home physio app ease pelvic pain? small study hints yes
- New hope for Women's pelvic pain: light and physiotherapy put to the test