NCT02314429已完成1 期
Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
研究概览
简要总结
In this first-in-human volunteer phase I clinical trial, a vaginal ring that slowly releases lactic acid (racemic mixture) into the vaginal environment, will be inserted in healthy volunteering women and left in place for 7 days. The primary objective of this phase I study is to assess the safety and the tolerability of this new intravaginal delivery system.
The eventual goal of this and related studies is to develop a vaginal ring that reduces recurrences in women suffering from bacterial vaginosis, which is the commonest form of vaginal infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Good general physical and mental health
- •Presence of normal (lactobacilli-dominated) vaginal microbiota
- •Prepared to take oral contraception during the study
排除标准
- •Pregnancy
- •Lactation
- •Systemic disease
- •Menopause
- •Recent use of antibiotics (<1 week before entering the study)
- •Recent use of intravaginal products or devices (<1 week before enrolment)
- •Presence of vaginal infection
结局指标
主要结局
Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy
时间窗: 7 days after insertion
次要结局
- Assessment of vaginal pH(each 30 minutes for 4 hours after insertion, and then each 60 minutes for the next 4 hours)
研究者
研究点 (2)
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