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

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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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mycoses Urogenital Diseases Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oteseconazole (VT-1161) 150mg capsule

Drug

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

Primary outcomes

The proportion of subjects achieving clinical cure at 6-month,

Time frame: 6-month after the end of treatment

clinical cure，defined as the absence of signs and symptoms of VVC

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Beijing Tsinghua Chang Gung Hospital

Other

Registry information

Official study title

Non-interventional Real-World Study of Oteseconazole in the Treatment of Vulvovaginal Candidiasis

Acronym: VVC

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2030
First posted: Jul 1, 2025
Registry last updated: Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed