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

Completed

• Conditions: Vaginal Candida
• Interventions: Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)

• Registration Number: NCT03599323
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-07-10
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Primary Completion: 2021-07-07
• Study Completion: 2021-09-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-20
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1033

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Clotrimazole 1% (Empecid L Cream, BAYB5097)	Clotrimazole 1% (Empecid L Cream, BAYB5097)	Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Patterns and way of use of Empecid L Cream recorded in Questionnaire	Up to one month

Trial Locations

Locations (1)

Many Locations; 🇯🇵 Multiple Locations, Japan