NCT00556179已完成4 期
Local, National (Brazil), Multicentric, Open, Non-Controlled, Phase IV, Study of Lactoserum (Dermacyd Femina®), in Women at Reproductive Age, to Prevent Recurrence of Bacterial Vaginosis, During Three Months, After Standard Treatment With Metronidazole.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Rate of recurrence of bacterial vaginosis after three months of treatment.
研究概览
简要总结
The purpose of this study is to demonstrate if the use of Dermacyd can avoid the recurrence of bacterial vaginosis after three months of the standard treatment.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women in reproductive age
- •Confirmed cure of bacterial vaginosis after treatment with oral metronidazole.
- •Vaginal bacterioscopic examination negative for candida and trichomonas.
排除标准
- •Pregnant or breastfeeding women
- •Allergy to dermacyd
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
1
Experimental
干预措施: Lactoserum (Dermacyd Femina®) (Drug)
结局指标
主要结局
Rate of recurrence of bacterial vaginosis after three months of treatment.
时间窗: Three months
次要结局
- Quality of life(Three months)
- Vaginal Candidiasis(Three months)
- AE, particularly genital irritation (tolerability use of dermacyd)(During the study)
研究者
研究点 (1)
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