New gel aims to stop recurring vaginal infections
NCT ID NCT07234786
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a gel device called Multi-Gyn FemiTotal in 80 women with bacterial vaginosis or vaginal yeast infections. Participants use the gel for 7 days, and if symptoms clear, they are followed for 4 months to see if the infection returns. The goal is to see if the gel can both treat and prevent these common infections.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria 1. Age ≥ 18 years old. 2. Women suffering from VVC or BV at the time of inclusion: 3. For VVC: Subject with at least itching score \> 2 and crumbly white discharge. 4. 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, * 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". 5. Subject having given freely and expressly her informed consent. 6. 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. 7. 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 Exclusion Criteria: 1. Pregnant or nursing woman or planning a pregnancy during the study. 2. Subject suspected to be non-compliant according to the investigator's judgment. 3. Subject enrolled in another clinical trial during the study period on the vaginal area. 4. Subject having a known allergy or hypersensitivity to one of the components of the investigational device. 5. 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). 6. Subject with current genital malignancies. 7. Subject who had a chemotherapy treatment in the 6 months before inclusion. 8. Subject who had a radiotherapy treatment in the genito-urinary area in the 12 months before inclusion. 9. Subject using treatment for vaginal conditions, vaginal infections, or other intravaginal treatment at the time of inclusion. 10. Subject using antibiotics for any reason in the 14 days before inclusion. 11. Subject using vaginal douches and who do not wish to refrain using them during the clinical investigation. 12. Subject with a pessary. 13. Subject with a condition or receiving a medication which, in the investigator's judgment, put the subject at undue risk
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dr Farah Bolaky
RECRUITINGQuatre Bornes, Mauritius
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- New vaginal capsule aims to tackle stubborn bacterial vaginosis