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The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 vs. Fluconazole In Subjects with Acute vulvovaginal Candidiasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | SHR8008 capsule |
|
| Treatment group B | Active Comparator | Fluconazole capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8008 capsule | Drug | once daily for 2 days(Day 1 and Day 2),oral |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects therapeutic cure | Day 14 | |
| The proportion of subjects with clinical cure | defined as absence of signs and symptoms of VVC | Day 14 and Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | 102200 | China |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Fluconazole Controlled, Multicenter Phase III Clinical Study
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| Fluconazole capsule |
| Drug |
once daily for 2 days(Every 72 hours) ,oral |
|
| The proportion of subjects with mycological cure | defined as negative culture of vaginal swabs for growth of Candida species | Day 14 and Day 28 |
| Changes from baseline in VVC signs and symptoms score | Day 14 and Day 28 |
| The proportion of subjects receiving rescue therapy during the study | 28 days |