Clinical Study of a Vaginal Gel for the Treatment and Prevention of Vaginal Infections

Inclusion criteria

• 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,
• 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

Exclusion criteria

• 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.
• 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