Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC）
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oteseconazole (VT-1161) 150mg capsule.
- Who it may be relevant to
- Registry conditions: Vulvovaginal Candidiasis. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Non-interventional Real-World Study of Oteseconazole in the Treatment of Vulvovaginal Candidiasis
Overview
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.
Interventions
- Drug 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
Primary outcome measures
- The proportion of subjects achieving clinical cure at 6-month, [Time frame: 6-month after the end of treatment]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07044947 · MA-VVC-RWS-002