The efficacy and safety of a single dose of Clindesse vaginal cream versus a seven-dose regimen of Cleocin vaginal cream in patients with bacterial vaginosis.
OBJECTIVE
To determine whether a single dose of Clindesse vaginal cream is comparable in efficacy and safety to Cleocin vaginal cream administered once daily for 7 days in the treatment of bacterial vaginosis.


METHODS
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.
Faro
Sebastian
S
The Woman's Hospital of Texas, Houston, Texas 77054, USA.
Skokos
Campbell K
CK
D000282:Administration, Intravaginal; D000328:Adult; D000900:Anti-Bacterial Agents; D002981:Clindamycin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D016896:Treatment Outcome; D014622:Vaginal Creams, Foams, and Jellies; D016585:Vaginosis, Bacterial / Q000188:drug therapy*
D000900:Anti-Bacterial Agents; D014622:Vaginal Creams, Foams, and Jellies; D002981:Clindamycin; C007084:clindamycin phosphate