The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
196
Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral
Dosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe proportion of subjects with one or more culture-verified VVC episodes during the study.
Time frame: 50 weeks
The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase
Time frame: Day 14
The proportion of subjects with 2 culture-verified VVC episodes during the study.
Time frame: week 50
The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study.
Time frame: week 50
The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase and follow-up phase
Time frame: Week 3 through Week 50
The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase.
Time frame: Week 3 through Week 50
The proportion of subjects with clinical cure (defined as the absence of all signs and symptoms of VVC) at the end of induction phase .
Time frame: Day 14
The proportion of subjects with mycological cure (defined as vaginal swab culture negative for growth of Candida species) at the end of induction phase.
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Time frame: Day 14
The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase.
Time frame: Day 14
The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase.
Time frame: Day 14
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Time frame: Week 3 through Week 13
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Time frame: Week 3 through Week 13
The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase
Time frame: Week 3 through Week 26
The proportion of subjects with at least one positive culture for Candida species during the maintenance phase
Time frame: Week 3 through Week 26
The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase.
Time frame: Week 27 through Week 50
The proportion of subjects with at least one positive culture for Candida species during the follow-up phase
Time frame: Week 27 through Week 50