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The purpose of this study is to evaluate the Efficacy and Safety of SHR8008 capsule In Subjects With Recurrent Vulvovaginal Candidiasis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR8008 | Experimental |
| |
| Fluconazole | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR8008 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with one or more culture-verified VVC episodes during the study. | 50 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with resolved VVC episode (clinical signs and symptoms score of < 3) during induction phase | Day 14 | |
| The proportion of subjects with 2 culture-verified VVC episodes during the study. | week 50 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Cao, M.D | Contact | +0518-81220121 | yong.cao@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100005 | China |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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, active controlled, parallel groups, Multicenter Phase III Clinical Study
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| Fluconazole | Drug | 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 |
|
| The proportion of subjects with ≥ 3 culture-verified VVC episodes during the study. | week 50 |
| The proportion of subjects with one or more culture-verified VVC episodes during the maintenance phase and follow-up phase. | Week 3 through Week 50 |
| Time to first recurrence of a culture-verified VVC episode during the maintenance phase and follow-up phase. | 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 | Week 3 through Week 50 |
| The proportion of subjects receiving rescue treatment during the maintenance phase and follow-up phase. | 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 . | 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. | Day 14 |
| The proportion of subjects with therapeutic cure (clinical cure plus mycological cure) at the end of induction phase. | Day 14 |
| The proportion of subjects with therapeutic cure, clinical cure, and mycological cure during the maintenance phase. | Day 14 |
| The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase | Week 3 through Week 13 |
| The proportion of subjects with at least one positive culture for Candida species during the maintenance phase | Week 3 through Week 13 |
| The proportion of subjects with one or more culture-verified VVC episode during the maintenance phase | Week 3 through Week 26 |
| The proportion of subjects with at least one positive culture for Candida species during the maintenance phase | Week 3 through Week 26 |
| The proportion of subjects with one or more culture-verified VVC episodes during the follow-up phase. | Week 27 through Week 50 |
| The proportion of subjects with at least one positive culture for Candida species during the follow-up phase | Week 27 through Week 50 |
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |