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Cytolytic Vaginosis Multicentre Registry

U

University of Alberta

Status

Enrolling

Conditions

Cytolytic Vaginosis

Study type

Observational

Funder types

Other

Identifiers

NCT06228469
Pro00122929

Details and patient eligibility

About

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?

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

30 participants in 1 patient group

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

Trial contacts and locations

3

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Central trial contact

Roni Kraut, MD

Data sourced from clinicaltrials.gov

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