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

NCT03599323 | Completed

• 1 other identifier: 19439
• Study Type: observational
• Target: 1,033
• Locations: 1 country
• Sites: 1

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

Conditions

Vaginal Candida

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Patterns and way of use of Empecid L Cream recorded in Questionnaire

  Up to one month

Study Arms (1)

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)

Interventions

Clotrimazole 1% (Empecid L Cream, BAYB5097) DRUG

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).

Clotrimazole 1% (Empecid L Cream, BAYB5097)

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• \- 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• SATO PHARMACEUTICAL , Ltd.: collaborator

Study Sites (1)

Many Locations

Multiple Locations, Japan

Location

Related 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

MeSH Terms

Conditions

Candidiasis, Vulvovaginal

Interventions

Clotrimazole

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: July 10, 2018
• Primary Completion: July 7, 2021
• Study Completion: September 3, 2021
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

JP (1)