NCT02888197已完成不适用
A Non-Interventional Extension Study to Investigate Vulvovaginal Candidiasis Recurrence and Candida Colonization Following a Phase 2 Randomized, Active-Controlled Study of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 23
- 主要终点
- Time to recurrence of clinical signs/symptoms of VVC
研究概览
简要总结
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
详细描述
Following completion of the Phase 2, multicenter, randomized, active-controlled study of the safety and tolerability of two formulations of CD101 compared to fluconazole for the treatment of moderate to severe episodes of acute vulvovaginal candidiasis (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrollment in and completed the primary study through the Day 28 visit.
- •Received at least one dose of study drug in the primary study
- •Able to give written informed consent prior to completion of the primary study
排除标准
- •Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
- •Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
- •The Principal Investigator considers that the subject should not participate in the study
结局指标
主要结局
Time to recurrence of clinical signs/symptoms of VVC
时间窗: Up to Day 90 +/- 14 days
Time to recurrence of clinical signs/symptoms of VVC
次要结局
- Rate of candida colonization(Up to Day 90 +/- 14 days)
- Rates of recurrence of culture confirmed VVC(Up to Day 90 +/- 14 days)
- Rate of recurrence of clinical signs/symptoms of VVC(Up to Day 90 +/- 14 days)
- Time to recurrence of culture confirmed VVC(Up to Day 90 +/- 14 days)
研究者
研究点 (23)
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