A randomized clinical trial of the efficacy and safety of terconazole vaginal suppository versus oral fluconazole for treating severe vulvovaginal candidiasis Abstract Terconazole is a new, broad-spectrum, triazole antifungal agent. The aim of this study was to compare the efficacy and safety of a 6-day course of a terconazole vaginal suppository (80 mg) with two doses of oral fluconazole (150 mg) for the treatment of severe vulvovaginal candidiasis (SVVC). In this prospective, randomized

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... ontrol study, 140 consecutive patients with SVVC were enrolled at . Patients with SVVC, initially at a 1:1 ratio, were randomly assigned to receive treatment with either the terconazole vaginal suppository or oral fluconazole. The patients had follow-up visits at 7-14 days and 30-35 days following the last dose of therapy. The clinical cure rates in the terconazole group and the fluconazole group were, respectively, 81.0% (47/58) and 75.8% (50/66) at follow-up day 7-14 and 60.3% (35/58) and 56.1% (37/66) at day 30-35. The mycological cure rates in the two groups were, respectively, 79.3% (46/58) and 71.2% (47/66) at follow-up day 7-14 and 62.1% (36/58) and 53.0% (35/66) at day 30-35 (P > .05 for all). Local irritation was the primary adverse event associated with terconazole, whereas systemic side effects were associated with fluconazole; however, these effects were minimal. This study demonstrated that a terconazole vaginal suppository (80 mg daily for 6 days) was as effective as two dose of oral fluconazole (150 mg) in the treatment of patients with SVVC; as such, terconazole could be a choice for therapy of this disorder.