Trial Condition(s):
Vaginal Candida
Study on the safety of the approved product Empedic L Cream during its routine use (active ingredient is Clotrimazole 1%)
Bayer Identifier:
19439
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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 Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Many Locations Many Locations, Japan | Status Recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-8422937 |
Trial Design
Prospective, Non-interventional, post-marketing, multi-center, single-cohort, safety (questionnaire) investigation of Empecid L Cream (Clotrimazole 1%)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.Timeframe: Up to one month
- Types of AE recorded in QuestionnaireTimeframe: Up to one month
Secondary Outcome
- Patterns and way of use of Empecid L Cream recorded in QuestionnaireTimeframe: Up to one month
Additional Information
Not Available
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