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Oteseconazole is a novel, oral, highly selective inhibitor of fungal CYP51. Oteseconazole showed statistically significant and clinically meaningful treatment of severe VVC and was generally tolerated. The trial is a national multi-center, non-interventional observational real-world study, aiming to evaluate the effecacy and safety of oteseconazole in the treatment of patients with VVC. This study will include patients with severe vulvovaginal candidiasis (SVVC) . It is divided into prospective and retrospective parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oteseconazole | Subjects with SVVC will be treated with 600 mg (150 mg per capsule) on D1, 450 mg on D2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oteseconazole (VT-1161) 150mg capsule | Drug | Subjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieving clinical cure at 6-month, | clinical cure,defined as the absence of signs and symptoms of VVC | 6-month after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole | 1-month, 12-month, 24-month and 36-month after the end of treatment | |
| The time of the first clinical recurrence of VVC during the follow-up period |
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Inclusion Criteria:
Exclusion Criteria:
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3000
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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 |
|---|---|
| C000599187 | VT-1161 |
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| From enrollment to the end of treatment for 3 years" |
| Adverse events and serious adverse events from the time of signed consent to the end of the study | From enrollment to the end of treatment at 3 years |
| 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 |