Registry to understand cytolytic vaginosis
Cytolytic Vaginosis Multicentre Registry
This study is trying to learn more about cytolytic vaginosis by collecting information from women with symptoms to see what causes it and if baking soda vaginal rinses can help.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Locations | 3 sites (Niterói, Rio De Janeiro and 2 other locations) |
| Trial ID | NCT06228469 on ClinicalTrials.gov |
What this trial studies
This registry aims to gather data on cytolytic vaginosis, a controversial vaginal condition. It will enroll women exhibiting symptoms consistent with this condition to explore risk factors, defining symptoms, diagnostic features on wet mount, and the effectiveness of baking soda vaginal irrigations as a treatment. The registry will also investigate whether the characteristics of cytolytic vaginosis differ across various sites and countries. Data collected will include symptoms, test results, and treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this registry are women experiencing vaginitis symptoms with specific findings on wet mount.
Not a fit: Patients who are pregnant or have a positive test for yeast may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could enhance understanding and management of cytolytic vaginosis, leading to better treatment options for affected patients.
How similar studies have performed: While cytolytic vaginosis is a relatively unexplored area, similar observational studies have provided valuable insights into other vaginal conditions, suggesting potential for meaningful findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Vaginitis symptoms * Predominately lactobacilli or/and elongated lactobacilli on wet mount * Cytolysis on wet mount Exclusion Criteria: * Unable to consent or decline consent * Pregnant * Positive for yeast (culture or PCR)
Where this trial is running
Niterói, Rio De Janeiro and 2 other locations
- Universidade Federal Fluminense-UFF — Niterói, Rio De Janeiro, Brazil (Not_yet_recruiting)
- Outpatient clinics — Multiple Locations, Alberta, Canada (Recruiting)
- Centro Hospitalar de São João — Porto, Portugal (Recruiting)
Study contacts
- Study coordinator: Roni Kraut, MD
- Email: rkraut@ualberta.ca
- Phone: 780.492.8306
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.