Study Completed

Vaginal Candida

Bayer Identifier:

19439

ClinicalTrials.gov Identifier:

NCT03599323

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study on the safety of the approved product Empedic L Cream during its routine use (active ingredient is Clotrimazole 1%)

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

Key Participants Requirements

Sex

Female

Age

15 - 60 Years

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

1033

Trial Dates

July 2018 - September 2021

Phase

Phase 4

Could I Receive a placebo

Products

Mycelex-7 (Clotrimazole, BAYB5097)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Japan

Primary Outcome

Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.
Time Frame:
Up to one month
Types of AE recorded in Questionnaire
Time Frame:
Up to one month

Secondary Outcome

Patterns and way of use of Empecid L Cream recorded in Questionnaire
Time Frame:
Up to one month

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

N/A

Additional Information

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