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

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

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

Study Overview

• Status: Completed
• Conditions: Vaginal Candida
• Intervention / Treatment: Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)

• Study Type: Observational
• Enrollment (Actual): 1033

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 58 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The primary population of interest is composed of subjects 15 years or older and under 60 years who purchase Empecid L Cream.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: SATO PHARMACEUTICAL , Ltd.

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the NCT number or Bayer Study ID in the search field

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2018
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): September 3, 2021

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Clotrimazole; Miconazole
• Other Study ID Numbers: 19439

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No