NCT01201057已完成2 期
A Double-blind, Multi-center, Randomized, Placebo Controlled, Dose-ranging Study to Determine the Efficacy and Safety of SPL7013 Gel (VivaGel®) Administered Vaginally in the Treatment 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
- 132
- 试验地点
- 5
- 主要终点
- Number of Women With Clinical Cure as a Measure of Efficacy
研究概览
简要总结
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment 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
- Treatment
- 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 diagnosis of BV according to Amsel's criteria and a Nugent score of ≥4
- •Otherwise healthy
排除标准
- •No active STIs
研究组 & 干预措施
0.5% SPL7013 Gel
Experimental
干预措施: 0.5% SPL7013 Gel (Drug)
1.0% SPL7013 Gel
Experimental
干预措施: 1.0% SPL7013 Gel (Drug)
3.0% SPL7013 Gel
Experimental
干预措施: 3.0% SPL7013 Gel (Drug)
Placebo Gel
Placebo Comparator
干预措施: Placebo Gel (Other)
结局指标
主要结局
Number of Women With Clinical Cure as a Measure of Efficacy
时间窗: Day 21-30
Number of women with clinical cure as determined by absence of BV by the Amsel's criteria
次要结局
- Number of Women With Nugent Cure as a Measure of Efficacy(Day 9-30)
- Number of Women With Clinical Cure as a Measure of Efficacy(Day 9-12)
- Patient Perceived Symptom Resolution as a Measure of Efficacy (Odor)(Day 9-30)
- Incidence of Genital Adverse Events Potentially Related to Treatment(For the duration of the study (up to Visit Day 21-30))
研究者
研究点 (5)
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