check_circleStudy Completed
Vaginal Candida
Bayer Identifier:
19439
ClinicalTrials.gov Identifier:
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
FemaleAge
15 - 60 YearsTrial summary
Enrollment Goal
1033Trial Dates
July 2018 - September 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Mycelex-7 (Clotrimazole, BAYB5097)Accepts Healthy Volunteer
NoWhere 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.date_rangeTime Frame:Up to one month
- Types of AE recorded in Questionnairedate_rangeTime Frame:Up to one month
Secondary Outcome
- Patterns and way of use of Empecid L Cream recorded in Questionnairedate_rangeTime Frame:Up to one month
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A