NCT01437722已完成2 期
A Double-blind, Multicenter, Randomized, Placebo-controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally to Prevent the Recurrence of Bacterial Vaginosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 205
- 主要终点
- Number of women who have experienced a recurrent episode of BV as a measure of efficacy
研究概览
简要总结
The purpose in this clinical study is to determine the efficacy of SPL7013 Gel for the prevention of recurrence of bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 18-45 years with a history of recurrent BV, defined as at least 3 documented episodes in the previous 12 months (including the current episode).
- •Current episode of BV as defined by subject-reported symptoms and Amsel's Criteria
- •Otherwise healthy
排除标准
- •No active STIs and/or current UTI
- •Previous exposure to SPL7013 Gel
- •A Papanicolaou (Pap) smear result considered to be clinically significant (ie, high grade cervical intraepithelial squamous lesions [HSIL] on cytology or cervical intraepithelial neoplasia [CIN] grades of CIN2 or CIN3 on histology) in the previous 2 years or in accordance with local treatment guidelines.
研究组 & 干预措施
1% SPL7013 Gel
Experimental
干预措施: 1% SPL7013 Gel (Drug)
3% SPL7013 Gel
Experimental
干预措施: 3% SPL7013 Gel (Drug)
placebo gel
Placebo Comparator
干预措施: placebo gel (Drug)
结局指标
主要结局
Number of women who have experienced a recurrent episode of BV as a measure of efficacy
时间窗: Day 112 +/- 5
Number of women who have BV as measured by subject-reported symptoms and Amsel's Criteria
次要结局
未报告次要终点
研究者
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