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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03599323
Recruitment Status : Recruiting
First Posted : July 25, 2018
Last Update Posted : April 4, 2019
Sponsor:
Collaborator:
SATO PHARMACEUTICAL , Ltd.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Vaginal Candida Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


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).




Primary Outcome Measures :
  1. Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream. [ Time Frame: Up to one month ]
  2. Types of AE recorded in Questionnaire [ Time Frame: Up to one month ]

Secondary Outcome Measures :
  1. Patterns and way of use of Empecid L Cream recorded in Questionnaire [ Time Frame: Up to one month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599323


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937

Locations
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Japan
Many Locations Recruiting
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
SATO PHARMACEUTICAL , Ltd.

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03599323     History of Changes
Other Study ID Numbers: 19439
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No