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

Bayer

Status: Completed

Conditions: Vaginal Candida

Treatments: Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03599323

19439

Details and patient eligibility

About

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

Enrollment: 1,033 patients

Sex: Female

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,033 participants in 1 patient group

Clotrimazole 1% (Empecid L Cream, BAYB5097)

Description:

Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase.

Treatment:

Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)