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CompletedNCT06228469Updated Apr 14, 2026

Cytolytic Vaginosis Multicentre Registry

An observational study in Cytolytic Vaginosis, sponsored by University of Alberta. Completed at 3 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by University of Alberta · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
32
Ages
18 Years and older
Sex
Female
01

Study summary

The goal of this registry is to learn more about cytolytic vaginosis, a little known and controversial condition. The main questions the registry aims to answer are:

  • What are risk factors of cytolytic vaginosis?
  • Are there defining symptoms of cytolytic vaginosis?
  • What features on wet mount should be used to diagnosis cytolytic vaginosis?
  • Are baking soda vaginal irrigations an effective treatment for cytolytic vaginosis?
  • Do characteristics of cytolytic vaginosis vary between sites/countries?
Read the detailed description

Cytolytic vaginosis is a largely unknown, debated, and equivocal vaginal condition. It is unclear whether cytolytic vaginosis is a variant of normal vaginal microbiome or should be considered a vaginal dysbiosis condition, similar to bacterial vaginosis. This multicentre registry will enroll women that have signs/symptoms consistent with cytolytic vaginosis to better characterize it.

Women at participating sites diagnosed with cytolytic vaginosis and that provide consent will be consecutively enrolled in the registry. The registry will capture data on risk factors, symptoms, test results (eg, wet mount) and treatment outcomes.

02

Conditions studied

  • Cytolytic Vaginosis

Keywords

  • Vaginitis
  • Lactobacillus
  • Wet mount
  • Vaginal microbiome
  • Fragmented epithelial cells
  • Vaginal discharge
03

In context

Vaginitis

98 studies on the registry are indexed under Vaginitis; 12 are open to participants now.

This study's enrollment of 32 is below the median of 140 across 22 observational studies indexed under Vaginitis.

Browse Vaginitis studies →

Lead sponsor

University of Alberta is the lead sponsor of 823 studies on the registry; 169 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Women attending an outpatient clinic with vaginitis symptoms

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Vaginitis symptoms
  • Predominately lactobacilli or/and elongated lactobacilli on wet mount
  • Cytolysis on wet mount

Exclusion criteria

Exclusion Criteria:

  • Unable to consent or decline consent
  • Pregnant
  • Positive for yeast (culture or PCR)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
32 participants (actual)
Patient registry
No

Groups and cohorts

  • Women diagnosed with cytolytic vaginosis

    Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis.

06

What researchers measure

Primary outcomes

  1. Characterize cytolytic vaginosis

    Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis

    Time frame: 1 year

07

Study locations

3 sites
  • Universidade Federal Fluminense-UFF
    Niterói, Rio de Janeiro, Brazil
  • Outpatient clinics
    Multiple Locations, Alberta, Canada
  • Centro Hospitalar de São João
    Porto, Portugal
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06228469
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Mar 1, 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025
Last update
Apr 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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