Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections

Inclusion Criteria:

• Post-menarche women and premenopausal women, between 18 and 50 years old;

• Diagnosis of bacterial vaginosis (Amsel criteria), fungal (positive KOH test)or mixedvaginal infection;

• Patients who have regular menstrual cycles (patients with regular menstrual cycleswith intervals between 21 to 35 days, duration of 1 to 7 days)

Exclusion Criteria:

• Patients who have a known hypersensitivity to components of the formula ;

• Pregnant and lactating women ;

• Patients with other vaginal infections, such as infection by Trichomonas vaginalis ,C. trachomatis, Neisseria gonorrhoeae , herpes or HPV.

• Knowledge of positive test result for human immunodeficiency virus ;

• Patients in treatment of cervical intraepithelial neoplasia or carcinoma of the cervix ;

• Patients who have undergone gynecological procedures in the month prior to inclusion (such as cauterization of the cervix , cervical biopsy, high-frequency surgery) ;

• Patients with other vaginal or vulvar conditions that may confound interpretation ofclinical response;

• Patients who received intravaginal or systemic antimicrobial or antifungal therapy 14days before randomization ;

• Patients on immunosuppressive medications (such as corticosteroids , cyclosporine ,etc. ) ;

• Known or suspected cancer ;

• Participation in any experimental study or ingestion of any experimental drug 12months before the start of this study.