NCT01361048已完成2 期
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis
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
- 40
- 试验地点
- 1
- 主要终点
- Percentage of Participants Cured of Vaginal Trichmonas
研究概览
简要总结
The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.
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
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •presence of trichomonas
排除标准
- •pregnant or nursing
- •known immunodeficiency
- •allergy to study drugs
- •concurrent yeast infection
- •history of seizures or peripheral neuropathy
- •unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium
- •anticoagulation therapy, and abuse
- •patient expected to have menses within 8 days of enrollment
研究组 & 干预措施
oral metronidazole
Active Comparator
control arm
干预措施: oral metronidazole (Drug)
neo penotran forte
Experimental
neo penotran forte vaginal suppository twice a day for 7 days
干预措施: neo penotran forte (Drug)
neo penotran forte once a day
Experimental
neo penotran forte vaginal suppository once a day for 7 days
干预措施: neo penotran forte once a day (Drug)
结局指标
主要结局
Percentage of Participants Cured of Vaginal Trichmonas
时间窗: day 12-15
percentage of participants achieving microbiological cure of trichomonas
次要结局
- Tolerability of the Study Product as Measured by Participant Self-report(day 12-15 day 30-35)
研究者
Jane Schwebke
Professor of Medicine
University of Alabama at Birmingham
研究点 (1)
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