NCT01335373已完成不适用
Observational Program Neo-Penotran® Forte
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 13,024
- 主要终点
- Percent rate of different vaginal infections
研究概览
简要总结
Vaginitis is the most common gynecologic diagnosis in the primary care setting. In approximately 90 percent of affected women, this condition occurs secondary to bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis or mixed infection.
Neo-Penotran Forte is registered for treatment of these most common vaginal infections. Efficacy and safety of this product is already established, and this observational study was designed to learn more about practical use of Neo-Penotran® Forte in real life setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.
排除标准
- •Presence of contraindications according to package insert.
研究组 & 干预措施
Group 1
干预措施: Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276) (Drug)
结局指标
主要结局
Percent rate of different vaginal infections
时间窗: Approximately within 6 months after the last patient last visit.
次要结局
- Clinical characteristics of vaginitis after treatment.(Depending on treatment time chosen by the physician, after 7 or 14 days.)
- Change of microbiological characteristics after treatment(Depending on treatment time chosen by the physician, after 7 or 14 days.)
- Patient rating of tolerability and treatment results(Depending on treatment time chosen by the physician, after 7 or 14 days.)
- Physician's rating of tolerability and treatment results(Depending on treatment time chosen by the physician, after 7 or 14 days.)
研究者
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