Phase I Trial Evaluating the Safety of a Lactate Releasing Vaginal Ring for the Prophylaxis of Bacterial Vaginosis

University Ghent1 个研究点分布在 1 个国家目标入组 6 人开始时间: 2014年9月1日最近更新: 2016年3月14日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: University Ghent
入组人数: 6
试验地点: 1
主要终点: Absence/presence of visible cervicovaginal inflammation/irritation by colposcopy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

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

研究组 & 干预措施

Vaginal Ring

Experimental

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.

干预措施: Vaginal ring releasing lactic acid (racemic mixture) (Device)