Vaginal gel to treat and prevent bacterial vaginosis and yeast infections

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.

This trial will test whether a vaginal gel called Multi-Gyn FemiTotal can treat and prevent bacterial vaginosis and vulvovaginal candidiasis in adult women.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Karo Pharma AB (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Quatre Bornes)
• Trial ID: NCT07234786 on ClinicalTrials.gov

What this trial studies

This interventional study will enroll about 40 women with vulvovaginal candidiasis (VVC) and 49 women with bacterial vaginosis (BV) who meet specific diagnostic criteria. Participants will apply Multi-Gyn FemiTotal vaginal gel for 7 days during the treatment phase and be evaluated 21 days after treatment start for cure of BV (by Amsel criteria) and relief of VVC itching. Subjects judged cured at day 21 will enter a prevention follow-up and be monitored up to four months for recurrence. Inclusion requires adult women with either VVC (itching score >2 and crumbly white discharge) or BV (≥3 Amsel criteria with >20% clue cells) and use of effective contraception.

Who should consider this trial

Good fit: Adult women with confirmed BV by Amsel criteria (including >20% clue cells) or women with VVC who have an itching score >2 and characteristic crumbly white discharge are the intended participants.

Not a fit: Women without confirmed BV or VVC, those with severe infections requiring systemic therapy, or those who are pregnant are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the gel could offer a non‑systemic topical option to relieve itching and lower recurrence of BV and VVC.

How similar studies have performed: Some small trials of topical and non‑antibiotic vaginal products have shown symptom relief and reduced recurrence, but high‑quality evidence remains limited.

Eligibility criteria

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

Where this trial is running

Quatre Bornes

• Dr Farah Bolaky — Quatre Bornes, Mauritius (Recruiting)

Study contacts

• Study coordinator: Diana Zeneli, MD

Conditions Bacterial Vaginosis; Vaginal Candidiasis