A Multicenter, Open Label, Non-comparative, 3 Months Study to Assess the Performance and Safety of the New Medical Device Polybactum® in Reducing the Frequency of Recurrent Bacterial Vaginosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Amsel criteria laboratory diagnostic
研究概览
简要总结
The POLARIS trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study.
Interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients
详细描述
To evaluate the efficacy of Polybactum® administered for 3 cycles (one cycle/month) in reducing the rate of recurrence of BV in women cured with vaginal metronidazole and to compare the results of the treatment with the rate of recurrence reported in appropriate selected international literature. Therefore, the Polybactum® early administration should be able to modify the basal individual risk of BV recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women above 18 years.
- •BV diagnosed by Amsel criteria (see Annex 3) in the 6-9 days before study, and cured with metronidazole vaginal formulation (gel for 5 days or ovules for 7 days).
- •Diagnosis of RBV (at least 2 episodes of BV in the last 12 months including the BV cured before baseline).
- •Non lactating women or lactating non amenorrheic women.
- •Read and signed informed consent.
排除标准
- •Pregnancy.
- •Candidiasis or mixed vaginitis.
- •HIV or other immunodeficiency.
- •Known allergy to metronidazole or to Polybactum® ingredients.
- •Sex workers.
- •Menstruation or pre-menopause/menopause.
- •Patients concomitantly included in different interventional clinical trials.
- •Unwillingness to provide the informed consent to the trial.
- •Time between the last day of last menses and baseline visit > 16 days or ≤5 days.
研究组 & 干预措施
Polybactum®
Polybactum® ovules are administered intravaginally on 3 cycles, 1 cycle per month.
Polybactum is a medical device Class IIa used and marketed for the recurrence of Bacterial Vaginosis.
干预措施: Polybactum® (Device)
结局指标
主要结局
Amsel criteria laboratory diagnostic
时间窗: 3 months
Signs and symptoms of Bacterial Vaginosis assesed also by patients diary (vaginal discharge, burning, erythema, dyspareunia)
次要结局
- Lactobacilli counting(3 months)