. 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 5 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 TM and Cleocin 1 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 4 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).