Bacterial VaginosisNCT07234786
Multi-Gyn FemiTotal for the Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis
A study testing Multi-Gyn FemiTotal in people with Bacterial Vaginosis and Vaginal Candidiasis, run by Karo Pharma AB at 1 site in Mauritius.
Trial summary
The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Vaginal Candidiasis
- What is being tested?
- Multi-Gyn FemiTotal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteMauritius
- Study dates
- 22 Oct 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥ 18 years old.
- Women suffering from VVC or BV at the time of inclusion:
- For VVC: Subject with at least itching score > 2 and crumbly white discharge.
- For BV: Subject with at least 3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%).
- Amsel criteria used for the study:
- Thin, white, yellow, homogeneous discharge,
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- Clue cells on wet mount microscopy >20%,
- a vaginal fluid pH ≥4.5 when placing the discharge on litmus paper,
- Release fishy odor after adding 10% potassium hydroxide (KOH) solution to wet mount - also known as "whiff test".
- Subject having given freely and expressly her informed consent.
- Subject using a contraceptive regimen recognized as effective (pill, implant, Intra Uterine Device (IUD), condoms) since at least 12 weeks before inclusion visit and during the whole study.
- Subject cooperative and aware of the device's modalities of use and the necessity and duration of the follow-up visits so that perfect adhesion to the protocol can be expected
Who cannot join
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject enrolled in another clinical trial during the study period on the vaginal area.
- Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
- Subject suffering from a sexually transmitted gynaecological infection, genital tract infection or aerobic vaginitis (including clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
- Subject with current genital malignancies.
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- Subject who had a chemotherapy treatment in the 6 months before inclusion.
- Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion.
- Subject using treatment for vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion.
- Subject using antibiotics for any reason in the 14 days before inclusion.
- Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation.
- Subject with a pessary.
- Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johan Ohlson contact
Mauritius1 site, 1 recruiting
- Recruiting
Dr Farah Bolaky
Quatre Bornes
Farah Bolaky, MD
About this study
Official title: Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn FemiTotal for Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis.
The goal of this clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered as cured 21 days after the beginning of treatment, the subjects will be followed-up until Month 4 after treatment initiation to check the re-occurrence of VVC and BV (prevention phase).The primary objective is to evaluate the effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal Candidiasis (VVC) itching, 21 days after treatment initiation.
- Conditions
- Bacterial Vaginosis, Vaginal Candidiasis
- Being tested
- Multi-Gyn FemiTotal
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Gyn FemiTotalDevice
vaginal gel
| Study group | Role | What they receive |
|---|---|---|
| Study product | Experimental | Multi-Gyn Femitotal vaginal gel Receives: Device: Multi-Gyn FemiTotal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal candidiasis symptoms will be evaluated by the investigator and questionnaires.
Cured rated of subjects with BV will be evaluated based on Amsel criteria. Subjects with VVC will be evaluated based on improvement of the itch.
Measured: 21 days
Secondary outcomes (1)
The prevention of BV and VVC re-occurrence will be evaluated by the doctor, 4 months after using the product.
Percentage of subjects without relapse of BV or VVC, 4 months after treatment initiation.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start22 Oct 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Vaginal gel
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karo Pharma AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234786
- Sponsor's protocol ID
- 24-1774-U5 / 24INSE105
- Status last verified
- Sep 2026
- First submitted
- 25 Sep 2025
- Last updated
- 2 Oct 2026
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentric, Single Arm Clinical Investigation to Assess the Effectiveness and Safety of Multi-Gyn FemiTotal for Treatment and Prevention of Vulvovaginal Candidiasis Symptoms and Bacterial Vaginosis.
- ClinicalTrials.gov ID
- NCT07234786
- Acronym / sponsor ID
- 24-1774-U5 / 24INSE105
- Conditions
- Bacterial Vaginosis, Vaginal Candidiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Karo Pharma ABIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 18 Nov 2025 (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 clinical trial is to assess the safety and efficacy of Multi-Gyn Femitotal to treat and prevent women suffering from bacterial vaginosis and vulvo vaginal candidiasis. 40 subjects with itching symptoms of VVC and 49 subjects with BV as confirmed using Amsel criteria will be included and will use the device for 7 days (treatment phase). If the VVC symptoms and BV are considered as cured 21 days after the beginning of treatment, the subjects will be followed-up until Month 4 after treatment initiation to check the re-occurrence of VVC and BV (prevention phase).The primary objective is to evaluate the effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal Candidiasis (VVC) itching, 21 days after treatment initiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vaginal gel
| Arm | Type | Receives |
|---|---|---|
| Study product | Experimental | Device: Multi-Gyn FemiTotalMulti-Gyn Femitotal vaginal gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years old.
- Women suffering from VVC or BV at the time of inclusion:
- For VVC: Subject with at least itching score > 2 and crumbly white discharge.
- For BV: Subject with at least 3 out of 4 Amsel criteria positive, with at least presence of clue cells (>20%).
- Subject having given freely and expressly her informed consent.
Key exclusion criteria (13 listed)
- Pregnant or nursing woman or planning a pregnancy during the study.
- Subject suspected to be non-compliant according to the investigator's judgment.
- Subject enrolled in another clinical trial during the study period on the vaginal area.
- Subject having a known allergy or hypersensitivity to one of the components of the investigational device.
- Subject suffering from a sexually transmitted gynaecological infection, genital tract infection or aerobic vaginitis (including clinical obvious gonorrhoea, chlamydia trachomatis or mycoplasma genitalium infection with cervicitis, urethritis, salpingitis).
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 |
|---|---|---|
| Multi-Gyn FemiTotalvaginal gel | Device | Study product |
Primary outcome
The effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal candidiasis symptoms will be evaluated by the investigator and questionnaires.
Time frame: 21 days
Cured rated of subjects with BV will be evaluated based on Amsel criteria. Subjects with VVC will be evaluated based on improvement of the itch.
1 secondary outcome
The prevention of BV and VVC re-occurrence will be evaluated by the doctor, 4 months after using the product.
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- 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.
Johan Ohlson contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Gyn FemiTotal in people with Bacterial Vaginosis and Vaginal Candidiasis, run by Karo Pharma AB 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 12 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Zeneli, MD (0031614706949, diana.zeneli@karo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effectiveness of Multi-Gyn FemiTotal for the treatment of Bacterial Vaginosis (BV) and relief of VulvoVaginal candidiasis symptoms will be evaluated by the investigator and questionnaires. (time frame: 21 days). 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 2 Oct 2026.