NCT03599323

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
• Phase: —
• Study type: Observational
• Enrollment: 1,033 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 15 Years – 60 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2018-07-10
• Primary completion: 2021-07-07
• Completion: 2021-09-03
• First posted: 2018-07-26
• Last updated: 2022-07-22

Locations

1 site across 1 country: Japan