Copyright © 2005 Hindawi Publishing Corporation. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objective. To determine whether a single dose of Clindesse™ vaginal cream is comparable in efficacy and safety to Cleocinmml® vaginal cream administered once daily for 7 days in the treatment of bacterial vaginosis.

Study design. This multicenter, randomized, single-blind, parallel-group study enrolled 540 patients with BV infections. Treatment consisted of either a single intravaginal dose of Clindesse™ or 7 daily doses of Cleocin® . Efficacy and safety were assessed 21–30 days after the start of treatment. The efficacy endpoints were Investigator Cure, Clinical Cure (a composite of all 4 Amsel's criteria and Investigator Cure), Nugent Cure (Nugent score <4), and Therapeutic Cure (a composite of Clinical Cure and Nugent Cure). Resolution of individual Amsel's criteria was also evaluated. Treatment-emergent adverse events were monitored throughout the study.

Results. There were no significant differences in cure rates between the Clindesse™ and Cleocin® treatment groups in Investigator Cure (P = 0.702), Clinical Cure (P =0.945), Nugent Cure (P = 0.788), or Therapeutic Cure (P = 0.572). Results were also similar for 3 of 4 and 2 of 4 Amsel's criteria and for each individual Amsel's criterion (all P-values >0.200). Ninety-five percent confidence intervals for each endpoint were consistent with equivalence between the 2 products. There was no significant difference between the treatment groups in the incidence of treatment-emergent adverse events (P = 0.386).

Conclusions. A single dose of Clindesse™ vaginal cream is equivalent in safety and efficacy to a 7-dose regimen of Cleocin® vaginal cream in the treatment of bacterial vaginosis. This represents a significant advance in the treatment of bacterial vaginosis.