Vulvovaginal Candidiasis
Conditions
Interventions
Study group(Oteseconazole):Oteseconazole 450 mg on Day 1, 600 mg on Day 2, followed by 150 mg once weekly from Week 2 to Week 11.
Control group(Fluconazole): Fluconazole 150 mg on Days 1, 4, and 7, followed by 150 mg once weekly from Week 2 to Week 24.
Control group(Fluconazole induction – Oteseconazole consolidation):(Fluconazole induction – Oteseconazole consolidation): Fluconazole 150 mg on Days 1, 4, and 7
Oteseconazole 150 mg daily from Day 8 to Day 14
then Oteseconazole 150 mg once weekly from Week 3 to Week 11.
Sponsors
Obstetrics &Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 75 years old, female; 2. 4 or more episodes of VVC in the past 12 months; 3. VVC episodes (score >= 3) during screening; 4. Voluntary participation and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence has shown that the patient is a female in pregnancy or lactation period; 2. Planning a pregnancy within the next three years; 3. Patients who are participating in or planning to participate in other interventional clinical studies. 4. Patients with vaginitis attack or medication history of vaginitis within one week; Including but not limited to bacterial vaginosis (BV), aerobic vaginitis, trichomoniasis vaginalis, cytolytic vaginosis, acute cervicitis, pelvic inflammatory disease (PID), etc. attention should be paid to whether there is mixed infection. Such patients should be considered after treatment; 5. Hypersensitivity or intolerance to azole antifungals (e.g., oteseconazole, fluconazole, itraconazole); 6. Patients with malignant tumors, regardless of whether they have a history of chemoradiotherapy or not (if the number of patients enrolled does not meet the research needs, they can be included in patients with stable disease and no recurrence for more than 5 years, and patients with benign tumors without progression will not affect their enrollment); 7. Other situations determined by the researcher as unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with >=1 episode of VVC (score >=3) positive for Candida within 50 weeks after treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving clinical remission (VVC score <3) and clinical cure (VVC score = 0) of VVC episodes at the end of the induction and consolidation treatment period ;The time of the first episode of VVC during the consolidation treatment period and the follow-up period (weeks 26, 30, 38, and 50 after treatment).;Patient-Reported Outcomes; | — |
Countries
China
Contacts
Public ContactSui Long
Obstetrics & Gynecology Hospital of Fudan University
Outcome results
None listed