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

Vaginal Candida Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599323
• Other study ID #: 19439
• Status: Completed
• Start date: July 10, 2018
• Est. completion date: September 3, 2021

Study information

• Verified date: July 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1033
• Est. completion date: September 3, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vaginal Candida

Intervention

Drug:
• 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).

Locations

Country	Name	City	State
Japan	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	SATO PHARMACEUTICAL , Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.		Up to one month
Primary	Types of AE recorded in Questionnaire		Up to one month
Secondary	Patterns and way of use of Empecid L Cream recorded in Questionnaire		Up to one month

External Links

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