Improving diagnosis of vestibulodynia using omics approaches
Official title: Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis
Run by Fondazione IRCCS Policlinico San Matteo di Pavia · NCT06865963 · Data updated 2026-11-12
This study is trying to find better ways to diagnose vestibulodynia in women aged 18 to 50 by looking at biological samples to see if there are specific markers that can help identify this painful condition.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | Women only |
| Enrollment | 400 (estimated) |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Status | Recruiting |
| Started | June 25, 2024 |
| Main results expected | June 25, 2025 |
| Study ends | June 25, 2026 |
| Registry record updated | March 10, 2025 |
| Trial ID | NCT06865963 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 50 who experience provoked vestibulodynia and have abstained from intercourse and intravaginal products for the specified time prior to the visit.
✕Probably not a fit
Patients with generalized vulvodynia, endometriosis, or those who are pregnant or post-menopausal may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to enhance the diagnosis of vestibulodynia (VBD) and vulvodynia by utilizing an omics approach, which involves analyzing biological samples such as vulvar biopsies and blood samples. The study focuses on women aged 18 to 50 who experience provoked vestibulodynia, a common yet often overlooked condition affecting a significant portion of the female population. By collecting and analyzing molecular data, the study seeks to identify potential biomarkers that could lead to better recognition and understanding of this painful condition. The findings may help in developing more effective diagnostic tools and treatment strategies for those affected.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of vestibulodynia, ultimately enhancing the quality of life for affected women.
How similar studies have gone: While there is limited data on the specific omics approach for vestibulodynia, similar studies in other areas of women's health have shown promise in identifying biomarkers and improving diagnosis.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 50 * abstinence from intercourse for 7 days prior to the visit * non-use of intravaginal products for 7 days prior to the visit Exclusion Criteria: * patients whit generalized vulvodynia and those with only spontaneous, but not provoked vestibulodynia * Endometriosis * Pregnancy * Infectious vulvar disease * Post-menopause * Feeding time * gave birth within 4 months * received systemic or vaginal antimicrobial or probiotic therapy within 1 month before the visit
Where it's running
-
Fondazione IRCCS Policlinico San Matteo, SC Ostetricia e Ginecologia 1
Pavia, Pavia, Italy Recruiting
Study contacts
- Study coordinator: Barbara Gardella, MD
- Email: barbara.gardella@gmail.com
- Phone: +39 0382 50 3720
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Four-session focal shock wave therapy for vulvodynia in women
This study looks at whether four weekly sessions of low-intensity focal shock wave therapy help women with vulvodynia in real-life clinical practice.
-
Topical ketotifen 0.25% for secondary vestibulodynia
This Phase 2 trial will test whether applying ketotifen 0.25% cream to the vulvar vestibule reduces pain in adult women with secondary provoked vestibulodynia.
-
Interventions for managing pelvic health issues in women
This study is testing whether light therapy and physical therapy can help women with vulvar pain feel better over 14 weeks.
-
Testing low-dose naltrexone for vulvodynia pain relief
This study is testing if low-dose naltrexone can help women with vulvodynia feel less pain and improve their quality of life.
-
Creating a data bank to study vaginal conditions
This study is trying to understand how certain proteins and germs in the vagina might be linked to conditions like vulvodynia and recurrent infections by comparing women who have symptoms to those who don’t.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.