Prevention of Persistence of Bacterial Vaginosis: The Effects of High Dose Intravaginal Metronidazole
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights
研究概览
简要总结
This purpose of this study will be to conduct a double-blind, randomized, controlled clinical trial to determine the association between intravaginal high dose metronidazole (750mg), intravaginal high dose metronidazole combined with an antifungal agent(750mg metronidazole + 200mg miconazole) and low dose (37.5mg) intravaginal metronidazole, with the rate of persistent 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women 18-40 yrs old
- •abnormal vaginal discharge or malodor
- •positive QuickVue test
- •positive KOH whiff test
- •Positive finding of clue cells greater than or equal to 20% on wet mount
- •Able to give informed consent
- •willing to abstain from alcohol during the 5 day therapy and 1 day following
排除标准
- •immunocompromised women
- •symptomatic VVC
- •pregnancy or positive pregnancy test
- •menstruating or breastfeeding women
- •other oral or vaginal antifungal or antimicrobial drugs w/in past 2 wks
- •women with MPC, PID
研究组 & 干预措施
1
intravaginal metronidazole 750mg + 200mg miconazole
干预措施: intravaginal metronidazole (Drug)
2
intravaginal metronidazole 750mg
干预措施: intravaginal metronidazole (Drug)
3
intravaginal metronidazole 37.5mg
干预措施: intravaginal metronidazole (Drug)
结局指标
主要结局
The specific aim of this study is to compare the rate of persistence of BV in non-pregnant women randomized to one of three different schemes of intravaginal metronidazole given nightly for 5 nights
时间窗: 28 days after therapy initiation
次要结局
未报告次要终点