Metronidazole Vaginal Gel 0.75% (ZidovalTM) for Suppresion of Recurrent Bacterial Vaginosis (BV): A Pilot Clinical Trial

Objectives: A pilot efficacy and tolerability trial of suppressive metronidazole vaginal gel in reducing recurrent symptomatic relapses of bacterial vaginosis (BV). Study design: A prospective open labeled study. Women with recurrent BV were assigned to metronidazole gel 3 times monthly for 24 weeks. The mean episodes of relapses of recurrence of BV after metronidazole suppression was compared to historical mean obtained from the same participants by a paired-sample T test. An exit interview was used to record patient satisfaction. Results: The mean symptomatic relapses of BV was 0.44 (SD1.09). Historically, participants had a mean of 6.5 (SD3.09) by clinical or laboratory criteria, and a mean of 3.75 (1.06) by laboratory criteria only. Compared with each of the historical means by paired-sample T test, the difference is significant in both at P<0.0001. Adverse effects were uncommon. Conclusions: Suppressive therapy of BV with metronidazole gel for 3 days after the menstrual cycle resulted in significant reduction in symptomatic relapses. Adverse effects were uncommon. A randomized controlled trial is needed to further validate these results.