Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

The objective of this study is to evaluate the safety and effectiveness of Lactal Gel, a new medical device that is administered vaginally for the treatment of bacterial vaginosis (BV). One group of patients aged 18 years or older who have been diagnosed with BV according to the Amsel criteria will be treated with the tested device for one week. This treatment will be in accordance with the instructions for use of the tested device and the standard usual care of the involved center. The administration of any preparations that may influence the study outcome within the previous three weeks (e.g., antibiotics, antimycotics, probiotics) is prohibited. To diagnose BV, the presence of at least three of the following is required: * pH \>4.5; * increased thin vaginal discharge; * amine odor when KOH (Potassium Hydroxide) solution is added to vaginal secretions (Whiff test); * presence of clue cells in wet preparations. Patients will be visited at baseline and at day 11 ± 2 (final visit). The primary outcomes are: * percentage of BV-free subjects at the final visit. * Amsel criteria total score at the final visit. Secondary outcomes are the following: * patient evaluation for subjective odor, discomfort, and itching * investigator and patient global evaluation of performance * safety evaluation by collection of adverse events and by a global safety evaluation performed by patient and investigator * assessment of patient satisfaction and usability of the tested device If the results of this study are positive, the new medical device under development has the potential to become a valuable tool for gynecologists. It will be useful in cases where antibiotic treatment is not the preferred option for treating bacterial vaginosis.