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.

Autor: Faro S; The Woman's Hospital of Texas, Houston, Texas 77054, USA., Skokos CK
Jazyk: angličtina
Zdroj: Infectious diseases in obstetrics and gynecology [Infect Dis Obstet Gynecol] 2005 Sep; Vol. 13 (3), pp. 155-60.
DOI: 10.1080/10647440500148321
Abstrakt: 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.
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.
Databáze: MEDLINE
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