The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
322
once daily for 2 days(Day 1 and Day 2),oral
once daily for 2 days(Every 72 hours) ,oral
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
The proportion of subjects with therapeutic cure
defined as absence of signs and symptoms of VVC plus negative culture of vaginal swabs for growth of Candida species
Time frame: Day 28
The proportion of subjects therapeutic cure
Time frame: Day 14
The proportion of subjects with clinical cure
defined as absence of signs and symptoms of VVC
Time frame: Day 14 and Day 28
The proportion of subjects with mycological cure
defined as negative culture of vaginal swabs for growth of Candida species
Time frame: Day 14 and Day 28
Changes from baseline in VVC signs and symptoms score
Time frame: Day 14 and Day 28
The proportion of subjects receiving rescue therapy during the study
Time frame: 28 days
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