A randomized controlled trial of a new ovule formulation of ornidazole for the treatment of bacterial vaginosis

OBJECTIVE: To compare the efficacy of 500 mg ornidazole vaginal ovules (VO) and vaginal tablets (VT) in the treatment of bacterial vaginosis. METHOD: Patients were allocated at random to one group of 50 subjects to be treated with a VO (500 mg) prepared in our laboratory and to a second group of 50 subjects to be treated with a VT of ornidazole (500 mg). Therapeutic efficacy was assessed by Nugent's scoring system and clinical criteria (Amsel's criteria) before and 1 week after treatment. RESULTS: At the first follow-up visit, complete disappearance of the signs and symptoms or highly significant reduction in intensity of symptoms was observed in both treatment groups. No significant difference was evident between the two ornidazole formulations.