NCT03599323已完成不适用
Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)
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
- 1,033
- 试验地点
- 1
- 主要终点
- Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.
研究概览
简要总结
Researchers already did trials that showed Empecid L Cream worked for patients with Vaginal yeast infection who were in those trials. In this trial, they want to learn if consumers that use the cream under the guidance of a pharmacist have any medical problems during the trial
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consumers who self-select and are then deemed appropriate users of the product by the pharmacist for treatment of Vulvar itching with rash due to recurrent vaginal candida (only in patients previously diagnosed and treated by a doctor).
排除标准
- •Patient with first episode
- •Patient with allergy to Empecid Cream (Clotrimazole)
- •Patient under 15 years old/ beyond 60 years old
- •Pregnant women or women who may possibly be pregnant
- •Patient with diabetes
- •Patient who repeats indicated symptom frequently, have recurrent episodes (once every month or two, or twice or more within 6 months).
- •Patients who does not know whether it is a recurrence symptom
- •Patients who have a fever, chills, lower abdominal pain, back or shoulder pain, colored or bloody vaginal discharge, fishy-smelling vaginal discharge, cessation of menses, irregular or abnormal bleeding from the vagina, or ulcer, edema or erosion in the vagina or vulva suggesting they may have a different disease.
研究组 & 干预措施
Clotrimazole 1% (Empecid L Cream, BAYB5097)
Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase.
干预措施: Clotrimazole 1% (Empecid L Cream, BAYB5097) (Drug)
结局指标
主要结局
Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.
时间窗: Up to one month
Types of AE recorded in Questionnaire
时间窗: Up to one month
次要结局
- Patterns and way of use of Empecid L Cream recorded in Questionnaire(Up to one month)
研究者
研究点 (1)
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