A 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 24
- 主要终点
- Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
研究概览
简要总结
The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.
详细描述
This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), & Day 28 (+/-7 days) to assess therapeutic cure and safety.
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
- None
盲法说明
Sponsor blinded
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
- •moderate to severe acute vulvovaginal candidiasis (severity score >7)
- •positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
- •vaginal pH <4.5 for subjects with positive potassium hydroxide wet preparation
- •able to give written informed consent
排除标准
- •receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
- •known or suspected infectious causes of vulvovaginitis other than candidiasis
- •history of genital herpes
- •planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
- •need for non-protocol systemic or vaginal antifungal therapy
- •history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
- •pregnant females
- •females who are breast feeding
- •women intending to become pregnant during the study period
- •recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
- •subjects who use or anticipate use of intravaginal products
- •have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study
研究组 & 干预措施
Cohort 1
CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.
干预措施: CD101 Vaginal Gel (3%) (Drug)
Cohort 1
CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.
干预措施: CD101 External gel (1%) (Drug)
Cohort 2
CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.
干预措施: CD101 Vaginal Ointment (6%) (Drug)
Cohort 2
CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.
干预措施: CD101 External ointment (1%) (Drug)
Cohort 3
Oral fluconazole (150mg) administered on day 1.
干预措施: Fluconazole (Drug)
结局指标
主要结局
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
时间窗: Day 28 - 35
adverse events, clinical chemistry and hematology, pelvic exams
次要结局
- Change in Vulvovaginal Scoring System(Day 28 - 35)
- Mycological Culture(Day 28 -35)