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%)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03599323

Enrollment

1033

Registered

2018-07-26

Start date

2018-07-10

Completion date

2021-09-03

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vaginal Candida

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

Interventions

DRUGClotrimazole 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).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

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

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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026