Performance and Safety of Lactal Gel for Treatment of Bacterial Vaginosis

Inclusion Criteria: Participation was based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study. * Age ≥ 18 years old, including women of non- childbearing potential such as women after menopause, i.e 12 months after last menstruation * Newly diagnosed BV episode, based on Amsel criteria (Amsel et al., 1983), i.e. presence of three of the following criteria: increased homogeneous thin vaginal discharge; pH of the secretion \>4.5; amine odor when potassium hydroxide (KOH) 10% solution is added to a drop of vaginal secretions; presence of clue cells in wet preparations. * Suffering from symptoms associated with BV, such as unusual vaginal discharge, odour and discomfort * Having access to a smartphone or a computer with an internet access and familiar with the use thereof * to use the Investigational Medical Device (IMD) as recommended (in particular, for 7 consecutive days during the non-bleeding period of the menstrual cycle) * to avoid the use of any other interventional options for BV during the study (other than the IMD) * to avoid the use of any other intravaginal product (e.g. suppositories, gels, foams, lubricants, disinfectants, chemically based contraceptives etc.) during the study * to fill in the electronic Diary (eDiary) * Commitment to use contraception methods (with the exception of those defined in the previous inclusion criterion) * Readiness not to participate in another clinical study during this study * Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at baseline visit Exclusion Criteria: * Known allergy or hypersensitivity to the components of the IMD (self-reported) * Manifested or suspected Candida infection or any other vaginal mycosis * Trichomoniasis * Urogenital (dipstick testing), anal or rectal infection within the 3 weeks prior to (self-reported) / at baseline * History of recurrent genital herpes (self-reported) * Lesions/infections in the vaginal area * Use of preparations that may influence the study outcome within the last 3 weeks prior to Baseline and during the study (e.g. antibiotics, antimycotics, probiotics, corticosteroids etc.) * History in the past 6 months prior to baseline or presence of a sexually transmitted disease (self-reported) * History or presence of any other clinically significant known (self-reported) condition/disorder, which per investigator's judgement could interfere with the results of the study or the safety of the subject * Pregnancy, nursing or within first 3 months post-partum * History of or current abuse of drugs, alcohol or medication * Participation in another study during the last 30 days prior to baseline * Any other reason for exclusion as per investigator's judgment, e.g. insufficient compliance with study procedures