Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)

Study Overview
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Brief Summary
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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

Official Title
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Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)

Conditions
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Vaginal Candida

Intervention / Treatment
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* Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clotrimazole 1% (Empecid L Cream, BAYB5097)<br>Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase. | Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream. |  | Up to one month | 
| Types of AE recorded in Questionnaire |  | Up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns and way of use of Empecid L Cream recorded in Questionnaire |  | Up to one month |