A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oteseconazole (VT-1161) Oral Capsules in the Treatment of Subjects With Recurrent Vulvovaginal Candidiasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 425
- 试验地点
- 14
- 主要终点
- Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population.
研究概览
简要总结
Recurrent vulvovaginal candidiasis (RVVC), also known as recurrent yeast infections, is defined as at least 3 episodes of acute VVC in the past 12 months. Several properties of oteseconazole (VT-1161) suggest that it might be a safer and more effective treatment for RVVC than other oral antifungal medicines.
This study will evaluate the effectiveness and safety of oteseconazole (VT-1161) for the treatment of RVVC and consists of 2 parts. The first part of the study is a 2-week period for the treatment of the patient's current VVC episode with 3 150mg doses of fluconazole. The 2nd part consists of 12 weeks, when the patient will take either oteseconazole (VT-1161) 150 mg or a placebo (according to a random assignment), and then a 36-week follow-up period.
In addition, at participating sites, an amendment to the study allows US patients who complete the initial 48 weeks without experiencing a confirmed RVVC episode to continue in a 48-week observational extension period designed to evaluate the continued effectiveness of oteseconazole (VT-1161).
This study is identical to VMT-VT-1161-CL-011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •3 or more episodes of acute VVC in the past 12 months
- •Positive KOH or Gram stain test
- •Total vulvovaginal signs and symptoms score of ≥3 at screening visit
- •Total vulvovaginal signs and symptoms score of <3 at baseline visit
- •Must be able to swallow pills
排除标准
- •Presence or a history of another vaginal or vulvar condition(s)
- •Evidence of major organ system disease
- •History of cervical cancer
- •Poorly controlled diabetes mellitus
- •Recent use of topical or systemic antifungal or antibacterial drugs
- •Recent use of immunosuppressive or systemic corticosteroid therapies
研究组 & 干预措施
Oteseconazole (VT-1161) 150mg capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
干预措施: Oteseconazole (VT-1161) (Drug)
Placebo capsule
Once daily for 7 days starting at Day 1, followed by once weekly for 11 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects With 1 or More Culture-verified Acute VVC Episodes During the Maintenance Phase of the Study in the Intent-to-treat (ITT) Population.
时间窗: Maintenance phase (Baseline through Week 48)
The primary efficacy outcome measure was the percentage of subjects with 1 or more culture-verified acute VVC episodes during the maintenance phase (post-randomization through Week 48) in the intent-to-treat population. An acute VVC episode during the maintenance phase (considered a recurrent episode) was defined as a positive fungal culture for Candida species and a clinical signs and symptoms score of ≥3. To calculate the signs and symptoms score, each vulvovaginal sign (erythema, edema, excoriation) and symptom (itching, burning, irritation) was scored using the following scale, with a higher score indicating a worse outcome. 0 = none (complete absence of any sign or symptom), 1 = mild (slight), 2 = moderate (definitely present), 3 = severe (marked, intense)
次要结局
未报告次要终点