Flucovag: efficacy and safety in patients with vulvovaginal candidiasis: a prospective, multicenter, open-label, randomized, comparative clinical study

Design. A prospective, multicenter, open-label, randomized, comparative clinical study.

Objective. To compare the efficacy and safety of Flucovag (sertaconazole) vaginal suppositories, 300 mg (OTCPharm JSC, Russia; manufactured by Altpharm LLC, Russia) and the brand-name drug Zalain® (sertaconazole), 300 mg (Egis Pharmaceuticals PLC, Hungary) in the treatment of vulvovaginal candidiasis.

Materials and methods. The study included female patients (18–55 years old) with uncomplicated vulvovaginal candidiasis treated in outpatient settings. In total, 220 patients were randomized into two groups: group 1 (n=110) received a single dose of Flucovag vaginal suppositories, and group 2 (n=110) received a single dose of Zalain® vaginal suppositories. Seven days after the treatment, its clinical efficacy was evaluated. In case of incomplete clinical improvement after 7 days, patients received an additional dose of Flucovag (n=4) or Zalain (n=5) suppositories, respectively.

Results. At the end of therapy in the study groups, the clinical cure rates (99.1% vs. 96.3%, p≥0.05), microscopic, and culture results were comparable. No serious adverse events were reported in both groups throughout the study.

Conclusion. The study results demonstrate a favorable safety profile and high antifungal activity of sertaconazole.