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

NCT03599323 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1033

Last updated 2022-07-22

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • SATO PHARMACEUTICAL , Ltd.

    collaborator UNKNOWN

  • Bayer

    lead INDUSTRY

Eligibility

Min Age
15 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-10
Primary Completion
2021-07-07
Completion
2021-09-03

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03599323 on ClinicalTrials.gov