Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-10

Study Completion Date

2030-08-10

Brief Summary

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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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Detailed Description

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Conditions

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Vulvovaginal Candidiasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Oteseconazole

Subjects with SVVC will be treated with 600 mg (150 mg per capsule) on D1, 450 mg on D2

Oteseconazole (VT-1161) 150mg capsule

Intervention Type DRUG

Subjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2

Interventions

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Oteseconazole (VT-1161) 150mg capsule

Subjects with SVVC will be treated by Oteseconazole with 600 mg (150 mg per capsule) on D1, 450 mg on D2

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No