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OpenTrials
Completed

NCT Number: NCT03599323

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

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Key information

Conditions

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

Age range

15 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Many Locations

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  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 outcomes

  1. Patterns and way of use of Empecid L Cream recorded in Questionnaire

    Time frame: Up to one month

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • SATO PHARMACEUTICAL , Ltd.

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 26, 2018
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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