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Status unknownNCT05273333Updated Mar 10, 2022

Effect of Ultra-gyn® on Vulvovaginal Candidiasis

An interventional study of Ultra-gyn® in Vulvovaginal Candidiasis, Genital, sponsored by Biocodex. Status unknown at 1 site in Mauritius. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-03-10.

Sponsored by Biocodex · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
Female
01

Study 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)

02

Conditions studied

  • Vulvovaginal Candidiasis, Genital
03

In context

Candidiasis, Vulvovaginal

109 studies on the registry are indexed under Candidiasis, Vulvovaginal; 14 are open to participants now.

This study's planned enrollment of 30 is below the median of 126 across 91 interventional studies indexed under Candidiasis, Vulvovaginal.

Browse Candidiasis, Vulvovaginal studies →

Lead sponsor

Biocodex is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

To be eligible, each patient must satisfy the following criteria:

  1. Is a non-menopausal woman aged 18 to 45 years,
  2. Suffering from a vulvovaginal candidiasis (according to clinical examination),
  3. Who was being prescribed standard antifungal therapy for Vulvovaginal Candidiasis,
  4. Has regular menstrual cycles (21-35 days) or no menstruation due to continuous use of ,
  5. Is able to understand the study related information and to give a written ,
  6. Has signed the informed consent form before beginning any study procedure,
  7. Agrees not to use other vaginal products than those planned in the study protocol, during participation in the study,
  8. Agrees not to use a diaphragm, spermicide or latex condoms, contraceptive creams and spermicide ovules during participation in the study,
  9. Uses an effective method of contraception (contraceptive [oral, patch, injection, implant], intrauterine device, vasectomized partner, history of permanent sterilization such as tubal ligation, hysterectomy, etc.) or abstinence,
  10. Has no condition that may interfere with the study assessments
  11. Is affiliated to a health social security system,
  12. Is able to comply with protocol requirements and respect the conditions of the study,

Exclusion criteria

Exclusion Criteria:

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:

  1. Has had a sexually transmitted disease in the 21 days preceding screening or detected on this occasion,
  2. Has a history of recurrent fungaemia,
  3. 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),
  4. Has had pelvic surgery in the 3 months prior to screening,
  5. Has had uterine or vaginal bleeding of unknown etiology,
  6. ,
  7. Has any other severe chronic or acute medical or psychiatric condition that in the judgment of the Investigator, could interfere with the study assessments,
  8. Is pregnant (positive pregnancy test at screening), has given birth less than 2 months ago or is breastfeeding,

  9. Has changed her method of in the 2 months prior to screening,

    Criteria related to to the product used within the study:

  10. With a known allergy or presenting an to one of the component of the study product,

  11. 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

  12. 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,
  13. Is not willing to stop taking probiotics dietary supplements and food products enriched with probiotics,
  14. Is planning to change her usual habits (hygiene, dietary habits, tobacco and alcohol consumption, physical activity and sexual life) during the study,
  15. Has participated in an interventional clinical study in the month prior to inclusion.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Other
    Ultra-gyn®

    ovule

    Device: Ultra-gyn®

Interventions

  • DeviceUltra-gyn®

    Ultra-gyn® ovule intravaginal application, every evening before bedtime for a 10 days period.

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Day 0 to Day 30 (+/-5)

Secondary outcomes

  1. To assess the effect of Ultra-gyn® on Candida spp

    Change in vaginal load of Candida spp (CFU Enumeration)

    Time frame: Day 0 and Day 30 (+/-5)

  2. To assess the effect of Ultra-gyn® on vaginal microbiota

    Analysis with shotgun metagenomic sequencing of change in taxonomic composition of the vaginal microbiota

    Time frame: Day 0 and Day 30 (+/-5)

  3. To assess the incidence of adverse effects

    Number, nature and characteristics of any adverse reactions

    Time frame: Day 1 to Day 30 (+/-5)

  4. To assess the incidence of device deficiencies

    Number, nature and characteristics of any device deficiencies

    Time frame: Day 1 to Day 30 (+/-5)

07

Study locations

1 of 1 sites recruiting
  • IR
    Quatre Bornes, 60200, Mauritius
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2022 (actual). Primary completion is estimated for Jul 2022, 5 months after the start.

Of 20 interventional studies with no phase under Candidiasis, Vulvovaginal, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 5 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 9, 2022
First posted
Mar 10, 2022
StartActual
Feb 23, 2022
Primary completionEst.
Jul 2022
CompletionEst.
Dec 2022
Last update
Mar 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05273333
Lead sponsor
Biocodex
Responsible party
Sponsor
First posted
Mar 10, 2022
Start date
Feb 23, 2022
Primary completion
Jul 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Mar 10, 2022

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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