A Phase 3, Double-blind, Multicentre, Randomised, Placebo-controlled Study to Assess the Efficacy and Safety of SPL7013 Gel (VivaGel) for the Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
研究概览
简要总结
The primary objective of the study is to assess the efficacy of 1% SPL7013 Gel compared to placebo gel for the treatment of bacterial vaginosis (BV).
After screening eligible participants will be randomized to receive either 1% SPL7013 Gel or hydroxyethyl cellulose (HEC) placebo gel at a dose of 5g administered vaginally at bedtime for 7 consecutive days. Participants will be assessed for BV (both by Amsel criteria and Nugent score) at screening/Baseline, after last application (End of Treatment, EOT, Day 9-12) and at the final study visit approximately 2-3 weeks after last dose (Test of Cure, TOC, Day 21-30).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
VivaGel
干预措施: 1% SPL7013 Gel (Drug)
HEC Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Women With Clinical Cure at the End of Treatment Visit (EOT)
时间窗: Day 9-12
Clinical Cure is defined as the resolution of clinical findings (ie Amsel criteria) from the Baseline visit (Day 1)
次要结局
- Number of Women With Nugent Cure at the EOT Visit(Day 9-12)
- Number of Women With Clinical Cure at the Test of Cure Visit (TOC)(Day 21-30)
- Adverse Events Potentially Related to Treatment(Screening/baseline through TOC visit, Day 1-30)
- Number of Women With Nugent Cure at the TOC Visit(Day 21-30)