Objectives
Clindamycin vaginal cream 2% is indicated for the treatment of bacterial vaginosis. A single-dose formulation is currently available and utilizes a bioadhesive technology to minimize vaginal cream leakage versus conventional creams. Data from 3 multicenter clinical trials were pooled to gain a greater understanding of the tolerability of single-dose clindamycin for the treatment of bacterial vaginosis.
Methods
Adult women with bacterial vaginosis, defined as at least meeting all of Amsel’s criteria, received a 100-mg single intravaginal dose of clindamycin vaginal cream 2% (n=368) or matching placebo (n=85) in 1 single-blind (30-day test of cure), 1 double-blind (30-day test of cure), and 1 open-label study (18-day follow-up). Safety was assessed by monitoring adverse events (AEs) throughout the study (eg, to test of cure or early discontinuation visit), monitoring vital signs, and, in the 2 blinded studies, nonefficacy laboratory (eg, 10% KOH test for yeast) and culture testing (eg, Candida species, Chlamydia trachomatis, Herpes, Neisseria gonorrhoeae, Trichomonas vaginalis) were performed. Data were analyzed for all patients who received at least 1 dose of study drug. Pair-wise comparison P values were assessed with Bonferroni-adjusted significance level (0.025).
Methods
Adult women with bacterial vaginosis, defined as at least meeting all of Amsel’s criteria, received a 100-mg single intravaginal dose of clindamycin vaginal cream 2% (n=368) or matching placebo (n=85) in 1 single-blind (30-day test of cure), 1 double-blind (30-day test of cure), and 1 open-label study (18-day follow-up). Safety was assessed by monitoring adverse events (AEs) throughout the study (eg, to test of cure or early discontinuation visit), monitoring vital signs, and, in the 2 blinded studies, nonefficacy laboratory (eg, 10% KOH test for yeast) and culture testing (eg, Candida species, Chlamydia trachomatis, Herpes, Neisseria gonorrhoeae, Trichomonas vaginalis) were performed. Data were analyzed for all patients who received at least 1 dose of study drug. Pair-wise comparison P values were assessed with Bonferroni-adjusted significance level (0.025).
Stay updated, free articles. Join our Telegram channel
Full access? Get Clinical Tree
