Cytolytic VaginosisNCT06228469
Cytolytic Vaginosis Multicentre Registry
An observational study of Cytolytic Vaginosis, run by University of Alberta at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cytolytic Vaginosis
- How many people
- 32 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women attending an outpatient clinic with vaginitis symptoms
Who may be able to join
- Vaginitis symptoms
- Predominately lactobacilli or/and elongated lactobacilli on wet mount
- Cytolysis on wet mount
Who cannot join
- Unable to consent or decline consent
- Pregnant
- Positive for yeast (culture or PCR)
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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.
- Conditions
- Cytolytic Vaginosis
- Keywords
- Vaginitis, Lactobacillus, Wet mount, Vaginal microbiome, Fragmented epithelial cells, Vaginal discharge
- Medical subject headings
- Vaginitis, Vaginal Discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with cytolytic vaginosis | Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize cytolytic vaginosis
Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start1 Mar 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytolytic VaginosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228469
- Sponsor's protocol ID
- Pro00122929
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2024
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytolytic Vaginosis Multicentre Registry
- ClinicalTrials.gov ID
- NCT06228469
- Acronym / sponsor ID
- Pro00122929
- Conditions
- Cytolytic Vaginosis
- Keywords
- Vaginitis, Lactobacillus, Wet mount, Vaginal microbiome, Fragmented epithelial cells, Vaginal discharge
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with cytolytic vaginosis | – | –Women presenting to an outpatient clinic with vaginitis symptoms and diagnosed with cytolytic vaginosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women attending an outpatient clinic with vaginitis symptoms
Key inclusion criteria (3 listed)
- Vaginitis symptoms
- Predominately lactobacilli or/and elongated lactobacilli on wet mount
- Cytolysis on wet mount
Key exclusion criteria (3 listed)
- Unable to consent or decline consent
- Pregnant
- Positive for yeast (culture or PCR)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Characterize cytolytic vaginosis
Time frame: 1 year
Describe the risk factors, symptoms, signs and treatment outcomes of cytoytic vaginosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytolytic Vaginosis, run by University of Alberta at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, Canada, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize cytolytic vaginosis (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.