The objectives of this study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppositories, 80 mg and fluconazole in the treatment of subjects with severe vulvovaginal candidiasis.
This study were to demonstrate comparable safety and efficacy of Terconazole Vaginal Suppository 80 mg inserted intravaginally once daily before bedtime for 6 consecutive days and oral fluconazole 150mg at day 1 and day 4 in the treatment of subjects with severe vulvovaginal candidiasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
Peking University Shenzhen Hosptal
Shenzhen, Guangdong, China
Mycological Cure 1
Based on candida culture
Time frame: Between day 7-14 after treatment, an average of 10 days
Mycological Cure 2
Based on Candida culture
Time frame: Between day 28-35 after treatment, an average of 30 days
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