Vulvovaginal Candidiasis
Conditions
Brief summary
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.
Interventions
Subjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2
Sponsors
Beijing Tsinghua Chang Gung Hospital
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects achieving clinical cure at 6-month, | 6-month after the end of treatment | clinical cure，defined as the absence of signs and symptoms of VVC |
Secondary
| Measure | 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 | 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 |
Outcome results
None listed