NCT00446979已完成1 期
Phase I Study of the Safety and Acceptability of UC-781 Topical Vaginal Microbicide in Women and Acceptability in Their Male Partners,Chiang Rai, Thailand
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
研究概览
简要总结
This study will help determine whether UC-781 gel is safe when applied to the vagina twice daily for 14 days, and will assess whether women and men find the gel acceptable to use.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
UC 781 0.1% carbomer gel
干预措施: UC 781 (Drug)
2
Experimental
UC 781 0.25% carbomer gel
干预措施: UC 781 (Drug)
3
Placebo Comparator
Placebo vaginal gel
干预措施: Placebo gel (Drug)
结局指标
主要结局
Genital tract inflammation or epithelial disruption as assessed by naked eye and colposcopic inspection according to established guidelines
时间窗: 2 weeks
Symptoms of irritation
时间窗: two weeks
Changes in vaginal flora
时间窗: Two weeks
Assessment of pro-inflammatory cytokines in the genital tract
时间窗: Two weeks
Other product-related adverse events
时间窗: Two weeks
次要结局
- acceptability of UC-781 gel use(Two weeks)
- systemic absorption of UC-781(Two weeks)
- anti-HIV activity of genital secretions in the presence of UC-781 gel(Two weeks)
研究者
研究点 (1)
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