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.


METHODS
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.
Baloğlu
E
E
Department of Pharmaceutical Technology, Faculty of Pharmacy, University of Ege, Izmir, Turkey. baloglue@pharm.ege.edu.tr
Ozyazici
M
M
Baloğlu
A
A
Ova
L
L
D000328:Adult; D000563:Amebicides / Q000008:administration & dosage / Q000627:therapeutic use*; D002626:Chemistry, Pharmaceutical; D005260:Female; D006801:Humans; D009950:Ornidazole / Q000008:administration & dosage / Q000627:therapeutic use*; D016896:Treatment Outcome; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000563:Amebicides; D009950:Ornidazole