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| Name | Class |
|---|---|
| SATO PHARMACEUTICAL , Ltd. | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clotrimazole 1% (Empecid L Cream, BAYB5097) | Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clotrimazole 1% (Empecid L Cream, BAYB5097) | Drug | 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). |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patterns and way of use of Empecid L Cream recorded in Questionnaire | Up to one month |
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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:
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The primary population of interest is composed of subjects 15 years or older and under 60 years who purchase Empecid L Cream.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many Locations | Multiple Locations | Japan |
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| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D003022 | Clotrimazole |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| D014848 |
| Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |