NCT06104098已完成不适用
A User Study With Vernivia® for Bacterial Vaginosis (USV01) Evaluation of User-friendliness, Measure Time From the Start of Treatment to Symptom Relief and the Clarity of Instructional Material
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pharmiva AB
- 入组人数
- 76
- 试验地点
- 14
- 主要终点
- Evaluate symptom relief during treatment with Vernivia®.
研究概览
简要总结
This is an open user study to evaluate D005 vagnial mousse with regards to user-friendliness, and measure time from start of treatment to symptom relief and measure the clarity of instructional material.
The study will be conducted at seven sites in Sweden, the study population will consist of up to 100 female subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 16 - 49 years Informed consent to take part in the study Bacterial vaginosis (based on self-assessment or diagnosed by a doctor or midwife) Access to a smartphone
排除标准
- •Symptoms of vaginal candida infection and/or Pregnancy
结局指标
主要结局
Evaluate symptom relief during treatment with Vernivia®.
时间窗: 1-7 days
Evaluation of number of days from start of treatment until symptom relief
次要结局
- Net Promotor Score regarding user-friendliness(1-7 days)
- Clarity of the IFU (Instructions For Use)(1-7 days)
- Clarity of instructional video(1-7 days)
- Self-reported grading of malodorous discharge (0-3)(1-7 days)
研究者
研究点 (14)
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