[Evaluation of efficacy of ketoconazole 800 mg-clindamycin 100 mg tablets vaginal against ketoconazole 800 mg- clindamycin 100 mg vaginal capsules in candida vaginitis and vaginosis].

BACKGROUND: pharmaceutical forms (presentations) influence treatment compliance and therefore the effectiveness. Here we present the results in the relief of vaginitis and vaginosis with two different dosage forms. OBJECTIVE: To compare the efficacy and safety of a combination of ketoconazole 800 mg + clindamycin in soft vaginal gel capsules 100 mg (vaginal capsules) against ketoconazole 800 mg + 100 mg clindamycin vaginal tablets (TV) in the management of vaginitis by C. albicans and/or vaginosis. MATERIAL AND METHOD: In a randomized, multicenter, comparative open label study, patients between 18 and 60 years with a diagnosis of vaginitis by C. albicans and/or vaginosis were included. Patients were evaluated clinically and direct exam of genital discharge and culture were performed. Patients were randomized to one of two treatments vaginal tablets or vaginal capsules, for 3 days. RESULTS: one hundred an sitxty nine patients were included, 85 in TV Group and 84 in vaginal capsules group. We found significant statistical difference in clinical response for tablet group at day three for burning p = 0.032 and itching p = 0.043. Microbiological cure was observed in patients with vaginitis by C. albicans, 92.5% in Group TV vs. 90.47% vaginal capsules group, all patients with G. vaginalis at baseline were negative for the organism at the end of the study, cure in patients with mixed infections were 78.94% for TV group vs. 78.26% vaginal capsules; group no adverse events were reported during treatment. CONCLUSIONS: Treatment of vaginitis/vaginosis with vaginal tablets is clinically better than vaginal soft gelatin capsules both treatments were well tolerated.