INTRODUCTION: To measure and compare the time of onset of symptomatic relief (the relief of vulvovaginal itching, burning, or irritation) in women with vaginal yeast infections who had either used a local vaginal antifungal preparation or systemic oral antifungal. METHODS: This is a randomized, double-parallel group study. Participants presenting with symptoms of vulvovaginal itching, burning, or irritation, who were diagnosed with vulvovaginal candidiasis by positive 10% potassium hydroxide wet preparation, were treated with either local vaginal antifungal preparation (1,200 mg miconazole nitrate ovule insert and 2% miconazole nitrate external vulvar cream) or systemic oral antifungal (150 mg fluconazole). First recorded time of symptom relief was summarized both separately by itching, burning, or irritation and for all symptoms combined based on change in total symptom scores. RESULTS: The median time to initial relief of symptoms of itching, burning, and irritation for the local vaginal antifungal preparation compared with systemic oral antifungal treatment group was 1.0 hours compared with 4.0 hours for individual symptoms and 4.0 hours compared with 16.0 hours for all the symptoms combined, respectively. For overall symptom relief, statistical significance was achieved between treatment groups for the time points 20 minutes, 40 minutes, and 1, 2, and 4 hours with P values <.004, <.017, <.002, <.007, and <.032, respectively. Greater than 72 hours postdose were not statistically significant. CONCLUSION: The local vaginal antifungal preparation system provided faster median times for initial relief of the vulvovaginal candidiasis symptoms of itching, burning, and irritation individually and for all symptoms combined than the systemic oral antifungal approach.
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