METHODS: This randomized, open-label, parallel study evaluated 181 female patients with moderate to severe symptoms of VVC. Patients were randomized to single-dose
therapy with either
butoconazole nitrate 2% Site Release
vaginal cream or
fluconazole. The primary outcome measure was the time to onset of first relief of symptoms. Secondary measures included the time to overall relief of symptoms and the
reinfection rate over the first 30 days following treatment. The overall safety of both products was investigated through the collection of adverse event reports.
RESULTS: The median time to first relief of symptoms occurred at 17.5 h for
butoconazole patients as compared to 22.9 h for
fluconazole patients (p < 0.001). The time at which 75% of patients experienced first relief of symptoms was 24.5 h versus 46.3 h for
butoconazole and
fluconazole, respectively (p < 0.001). By 12- and 24-h post-treatment, 44.4% and 72.8% of patients in the
butoconazole treatment group reported first relief of symptoms versus 29.1% and 55.7% of patients in the
fluconazole group (p = 0.044 and p = 0.024 respectively). In patients experiencing first relief of symptoms within 48 h of dosing, the median time to first relief of symptoms in the
butoconazole treatment group was significantly shorter at 12.9 h compared to 20.7 h for the
fluconazole treatment group (p = 0.048). There were no significant differences between the two groups with respect to time to total relief of symptoms or reoccurrence of
infection within 30 days of treatment.
Butoconazole therapy was shown to have fewer reported adverse events, including
drug-related adverse events, than
fluconazole therapy. Vulvovaginal
pruritus and vulvovaginal burning were the most common
drug-related adverse events attributed to
butoconazole.
Headache,
diarrhea,
nausea, upset stomach and skin sensitivity were the most common
drug-related adverse events attributable to
fluconazole.
CONCLUSIONS: Single-dose
butoconazole nitrate 2% Site Release
vaginal cream provides statistically significant improvement in time to first relief of symptoms in the treatment of VVC compared to
fluconazole. There is no difference between these two treatments with respect to total relief of symptoms or
reinfection rate. Although there was no significant difference in the incidence of adverse events judged by the investigator to be treatment-related,
butoconazole treatment did result in fewer patients experiencing adverse events than
fluconazole.