check_circleStudy 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
  • - 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).
  • - 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
No
Products
Mycelex-7 (Clotrimazole, BAYB5097)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Japan

Primary Outcome

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

Secondary Outcome

  • Patterns and way of use of Empecid L Cream recorded in Questionnaire
    date_rangeTime 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

Click here to find information for studies related to Bayer products. To find this study enter the NCT number or Bayer Study ID in the search field