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

Beijing Tsinghua Chang Gung Hospital

Status: Begins enrollment this month

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: Oteseconazole (VT-1161) 150mg capsule

Study type: Observational

Funder types: Other

Identifiers

NCT07044947

MA-VVC-RWS-002

Details and patient eligibility

About

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.

Enrollment: 3,000 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

3,000 participants in 1 patient group

Oteseconazole

Description:

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

Treatment:

Drug: Oteseconazole (VT-1161) 150mg capsule