Improving diagnosis of vestibulodynia using omics approaches
Vestibulodynia At High Resolution: Omics Approach to Improve Diagnosis
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 |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Fondazione IRCCS Policlinico San Matteo di Pavia Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT06865963 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with generalized vulvodynia, endometriosis, or those who are pregnant or post-menopausal may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Pavia, Pavia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.