Vulvovaginal CandidiasisNCT05327192
VVC Sampling Study for Analysis Validation
An observational study of Vulvovaginal Candidiasis, run by Gedea Biotech AB at 2 sites in United Kingdom.
Trial summary
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC. The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvovaginal Candidiasis
- How many people
- 10 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 12 May 2022to 6 Jul 2022
- 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: The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.
Who may be able to join
- Adult women aged 18 years or older
- Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
- At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
- Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
- Having decisional capacity and providing written informed consent
- Signed informed consent and willing and able to comply with all study requirements
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Research and Development Department, Berkshire Healthcare NHS Foundation Trust
Slough
About this study
Official title: Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.
The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.
Read more
Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.
Samples from a total of 10 women are planned to be taken.
- Conditions
- Vulvovaginal Candidiasis
- Being tested
- No intervention, only sampling
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, only samplingOther
No intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start12 May 2022
- Primary completion6 Jul 2022
- Study completion6 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal CandidiasisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedea Biotech AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327192
- Sponsor's protocol ID
- CL4-2
- Status last verified
- Aug 2022
- First submitted
- 7 Apr 2022
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method
- ClinicalTrials.gov ID
- NCT05327192
- Acronym / sponsor ID
- CL4-2
- Conditions
- Vulvovaginal Candidiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Gedea Biotech ABIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 6 Jul 2022 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 14 Apr 2022 (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.
This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.
The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.
Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.
Samples from a total of 10 women are planned to be taken.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.
Key inclusion criteria (6 listed)
- Adult women aged 18 years or older
- Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:
- Having decisional capacity and providing written informed consent
- Signed informed consent and willing and able to comply with all study requirements
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention, only samplingNo intervention | Other | – |
Primary outcome
Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.
Time frame: 1 day
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 18 Aug 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvovaginal Candidiasis, run by Gedea Biotech AB at 2 sites in United Kingdom.
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 6 inclusion and 1 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 18 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture. (time frame: 1 day). 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 18 Aug 2022; AzTrials last refreshed its copy on 27 Oct 2026.