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.
• 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