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

Not yet recruiting

• Conditions: Vulvovaginal Candidiasis

• Registration Number: NCT07044947
• Lead Sponsor: Beijing Tsinghua Chang Gung Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Study Start: 2025-08-10
• Primary Completion: 2027-08-10
• Study Completion: 2030-08-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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