Objectives: The author presents the results of the study aimed at verifying safety and efficacy of a single-dose vaginal administration of 2 % butoconazole nitrate (vaginal cream Gynazole 2 % RG) in a specific bioadhesive vehicle for treatment of acute vulvo-vaginal candidiasis. This study evaluated 311 female patients excluding those with the frequency of relapses more than 4 times per year. Study Design: After being diagnosed for acute vulvo-vaginal candidiasis the instructed patients self-applied the cream into the vagina. In the questionnaire they rated changes of subjective distress on a 4-point scale: before administration, after 20 minutes, after 4 hours, after 12 hours, after 24 hours, after 72 hours, on the 5th day and 7th - 10th day post-dosing. Effectiveness of treatment was evaluated also at 30 days post-dosing. Physicians assessed changes in objective findings in the follow-up at 7-10 days and 30 days post-dosing with using a 4-point scale as well. Results: The study confirmed fast initial symptom relief after cream administration. 50 % of patients experienced initial symptom relief within 24 hours and 75 % of patients within 48 hours after administration. 93.3 % of patients reported relief within 7- 10 days and 94.5 % within 30 days. Physicians reported relief of symptoms in 98.6 % of patients within 7-10 days and in 98.4 % within 30 days. Insufficient relief was reported in 1.3 % of patients on 7th day and in 1.6 % within 30 days. The total failure of treatment effectiveness was not recorded with respect to all cases.