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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1033 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-10

Study Completion Date

2021-09-03

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

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Detailed Description

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Conditions

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Vaginal Candida

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clotrimazole 1% (Empecid L Cream, BAYB5097)

Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase.

Clotrimazole 1% (Empecid L Cream, BAYB5097)

Intervention Type 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).

Interventions

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Clotrimazole 1% (Empecid L Cream, BAYB5097)

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).

Intervention Type DRUG

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.

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No