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.
≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy
Evidence has shown that the patient whohas been pregnant or lactating; Patients who are participating in or planning to participate in other interventional clinical studies; Other situations determined by the researcher as unsuitable for inclusion in the study
3000
Other
Other
Oteseconazole (VT-1161) 150mg capsule
DrugSubjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2
The proportion of subjects achieving clinical cure at 6-month,
clinical cure，defined as the absence of signs and symptoms of VVC
The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole
The time of the first clinical recurrence of VVC during the follow-up period
Adverse events and serious adverse events from the time of signed consent to the end of the study
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This trial is not recruiting at the moment. You can still explore other options:
