Safety and efficacy comparison of two dosing regimens of MetroGel-Vaginal(R) in the treatment of bacterial vaginosis: a multicenter, randomized, single-blind, parallel comparison.

Objective: To compare the safety and efficacy of 0.75% metronidazole vaginal gel (MGV) administered QD for 5 days to MGV administered BID for 5 days for the treatment of bacterial vaginosis (BV).Methods: Nonpregnant women 18 years or older with a diagnosis of BV were enrolled into this trial. Patients were determined to have BV if their vaginal discharge had >/=20% clue cells and if they had at least 2 of the following criteria: homogeneous discharge, positive KOH amine odor test, or vaginal pH >/=4.7. In addition, microbiologic confirmation of BV at baseline was required to be evaluable. Patients were evaluated at baseline and at 7-12 days after completion of therapy. If patients remained free of BV after therapy, they were evaluated at a follow-up visit 28-35 days after therapy.Results: A total of 514 patients were enrolled in the trial; 252 in the QD treatment group and 262 in the BID treatment group. Clinical cure rates based on patients considered evaluable at first return visits were 77% and 80% for QD and BID dosing regimens, respectively. Clinical cure rates based on patients considered evaluable at the final visit were 58% and 61% for QD and BID dosing regimens, respectively. Clinical cure rates at the final return visit based on intent-to-treat analysis were 53% and 57% for the QD and BID regimens, respectively. Two adverse events in two patients were reported as serious. Both adverse events resolved and neither event was judged to be related to therapy.Conclusion: MetroGel-Vaginal administered QD for 5 days was found to be as effective as MetroGel-Vaginal administered BID for 5 days in the treatment of bacterial vaginosis 28-35 days after therapy. The number of patients reporting adverse events judged to be related to therapy was also statistically comparable in both treatment groups.