Clinical trial Recruiting at 1 site Observational Ages 18 to 50 Women only

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 typeObservational
Ages18 Years to 50 Years
SexWomen only
Enrollment400 (estimated)
SponsorFondazione IRCCS Policlinico San Matteo di Pavia
Academic / other
Locations1 site (Pavia, Pavia)
StatusRecruiting
StartedJune 25, 2024
Main results expectedJune 25, 2025
Study endsJune 25, 2026
Registry record updatedMarch 10, 2025
Trial IDNCT06865963 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • 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.

    Recruiting Nantes University Hospital · Nantes, Nantes · NCT07553715

  • 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.

    Recruiting at 3 sites Phase 2 Center for Vulvovaginal Disorders · Washington D.C., District of Columbia and 2 other locations · NCT07257029

  • 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.

    Recruiting at 2 sites University of Ottawa · Ottawa, Ontario and 1 other locations · NCT06660212

  • 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.

    Recruiting Phase 2 Medical University of Lublin · Lublin · NCT05955313

  • 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.

    Recruiting Texas Tech University Health Sciences Center · Midland, Texas · NCT01829204

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.