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.
Study Type
OBSERVATIONAL
Enrollment
3,000
Subjects 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
Time frame: 6-month after the end of treatment
The proportion of patients with clinical recurrence within 1-month, 12-month, 24-month and 36-month after treatment with Oteseconazole
Time frame: 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
Time frame: 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
Time frame: From enrollment to the end of treatment at 3 years
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