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

NCT07044947 | Not Yet Recruiting

• 1 other identifier: MA-VVC-RWS-002
• Study Type: observational
• Target: 3,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvovaginal Candidiasis

Outcome Measures

Primary Outcomes (1)

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

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

  6-month after the end of treatment

Secondary Outcomes (3)

• 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

Study Arms (1)

Oteseconazole

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

Drug: Oteseconazole (VT-1161) 150mg capsule

Interventions

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

Oteseconazole

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

3000

You may qualify if:

• ≥ 18 years old, female; vulvovaginal signs and symptoms (VSS) score ≥7; Plan to use oteseconazole monotherapy or combination therapy

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

VT-1161

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 1, 2025
• Study Start: August 10, 2025
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): August 10, 2030
• Last Updated: July 1, 2025

Record last verified: 2025-06