Vulvovaginal Candidiasis, GenitalNCT05273333
Effect of Ultra-gyn® on Vulvovaginal Candidiasis
A study testing Ultra-gyn® in people with Vulvovaginal Candidiasis, Genital, run by Biocodex at 1 site in Mauritius.
Trial summary
The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Vulvovaginal Candidiasis, Genital
- What is being tested?
- Ultra-gyn®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMauritius
- Study dates
- 23 Feb 2022to Dec 2022
- Phase
- Interventional
- 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible, each patient must satisfy the following criteria:
- Is a non-menopausal woman aged 18 to 45 years,
- Suffering from a vulvovaginal candidiasis (according to clinical examination),
- Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
- Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
- Is able to understand the study related information and to give a written informed consent,
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- Has signed the informed consent form before beginning any study procedure,
- Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
- Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
- Uses an effective method of contraception (contraceptive steroid [oral, patch, injection, implant], intrauterine device, vasectomized partner, history of permanent sterilization such as tubal ligation, hysterectomy, etc.) or abstinence,
- Has no condition that may interfere with the study assessments
- Is affiliated to a health social security system,
- Is able to comply with protocol requirements and respect the conditions of the study,
Who cannot join
- Patients meeting at least one of the following criteria cannot be included in the study:
- Criteria related to a medical condition that would compromise patient safety or data fidelity:
- Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
- Has a history of recurrent fungaemia,
- Has a history of recurrent vulvovaginal candidiasis (defined as more than four episodes of vulvovaginal candidiasis in the previous year or two episodes in the last six months),
- Has had pelvic surgery in the 3 months prior to screening,
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- Has had uterine or vaginal bleeding of unknown etiology,
- Immunocompromised,
- Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
- Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,
- Has changed her method of contraception in the 2 months prior to screening,
- Criteria related to contraindications to the product used within the study:
- With a known allergy or presenting an hypersensitivity to one of the component of the study product,
- Presenting a contraindication or special warning to the study product, according to the package leaflet, including concomitant use of antifungal therapy during Ultra-gyn application,
- Criteria related to medications or situations that would interfere with or compromise data fidelity
- Has taken systemic or intravaginal antibiotic or antifungal agents (other than those prescribed during the inclusion visit) in the 14 days preceding the screening visit,
- Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
- Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
- Has participated in an interventional clinical study in the month prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Mauritius1 site, 1 recruiting
- Recruiting
IR
Quatre Bornes, 60200
Managing Director, 467 0231, contact@insight-research.com
Farah BOLAKY, MD
About this study
The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)
- Conditions
- Vulvovaginal Candidiasis, Genital
- Being tested
- Ultra-gyn®
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra-gyn®Device
Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period.
| Study group | Role | What they receive |
|---|---|---|
| Ultra-gyn® | Other | ovule Receives: Device: Ultra-gyn® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis
Change in vulvovaginal symptoms (5-point rating scale (ranging from 0 to 4, where 0=None and 4=Very severe) for vaginal itching, vaginal burning or soreness and vaginal discharge)
Measured: Day 0 to Day 30 (+/-5)
Secondary outcomes (4)
To assess the effect of Ultra-gyn® on Candida spp
Change in vaginal load of Candida spp (CFU Enumeration)
Measured: Day 0 and Day 30 (+/-5)
To assess the effect of Ultra-gyn® on vaginal microbiota
Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota
Measured: Day 0 and Day 30 (+/-5)
To assess the incidence of adverse effects
Number, nature and characteristics of any adverse reactions
Measured: Day 1 to Day 30 (+/-5)
To assess the incidence of device deficiencies
Number, nature and characteristics of any device deficiencies
Measured: Day 1 to Day 30 (+/-5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start23 Feb 2022
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulvovaginal Candidiasis, GenitalStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Prospective, Single-center, Open-label, Post-market Clinical Follow-up Study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocodex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273333
- Sponsor's protocol ID
- SbO216
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultra-gyn® on Vulvovaginal Candidiasis
- ClinicalTrials.gov ID
- NCT05273333
- Acronym / sponsor ID
- SbO216
- Conditions
- Vulvovaginal Candidiasis, Genital
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- BiocodexIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Mar 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.
The aim of this post-market clinical follow up study is to confirm the performance and the safety of Ultra-gyn® (when used in accordance with its approved labelling)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Prospective, Single-center, Open-label, Post-market Clinical Follow-up Study
| Arm | Type | Receives |
|---|---|---|
| Ultra-gyn® | Other | Device: Ultra-gyn®ovule |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Is a non-menopausal woman aged 18 to 45 years,
- Suffering from a vulvovaginal candidiasis (according to clinical examination),
- Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
- Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of contraception,
- Is able to understand the study related information and to give a written informed consent,
Key exclusion criteria (19 listed)
- Criteria related to a medical condition that would compromise patient safety or data fidelity:
- Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
- Has a history of recurrent fungaemia,
- Has a history of recurrent vulvovaginal candidiasis (defined as more than four episodes of vulvovaginal candidiasis in the previous year or two episodes in the last six months),
- Has had pelvic surgery in the 3 months prior to screening,
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 |
|---|---|---|
| Ultra-gyn®Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period. | Device | Ultra-gyn® |
Primary outcome
To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis
Time frame: Day 0 to Day 30 (+/-5)
Change in vulvovaginal symptoms (5-point rating scale (ranging from 0 to 4, where 0=None and 4=Very severe) for vaginal itching, vaginal burning or soreness and vaginal discharge)
4 secondary outcomes
To assess the effect of Ultra-gyn® on Candida spp
Time frame: Day 0 and Day 30 (+/-5)
To assess the effect of Ultra-gyn® on vaginal microbiota
Time frame: Day 0 and Day 30 (+/-5)
To assess the incidence of adverse effects
Time frame: Day 1 to Day 30 (+/-5)
To assess the incidence of device deficiencies
Time frame: Day 1 to Day 30 (+/-5)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra-gyn® in people with Vulvovaginal Candidiasis, Genital, run by Biocodex at 1 site in Mauritius.
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 13 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mauritius. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the effect of Ultra-gyn® in relieving the symptoms of Vulvovaginal Candidiasis (time frame: Day 0 to Day 30 (+/-5)). 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 10 Mar 2022.