Vaginal CandidaNCT03599323
Study on the Safety of the Approved Product Empedic L Cream During Its Routine Use (Active Ingredient is Clotrimazole 1%)
An observational study of Vaginal Candida, run by Bayer at 1 site in Japan.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 15 to 60 years, women only
- Conditions the study is for
- Vaginal Candida
- What is being tested?
- Clotrimazole 1% (Empecid L Cream, BAYB5097)
- How many people
- 1,033 participants
- Where
- 1 siteJapan
- Study dates
- 10 Jul 2018to 3 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: The primary population of interest is composed of subjects 15 years or older and under 60 years who purchase Empecid L Cream.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)
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
- Conditions
- Vaginal Candida
- Being tested
- Clotrimazole 1% (Empecid L Cream, BAYB5097)
- Medical subject headings
- Candidiasis, Vulvovaginal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clotrimazole 1% (Empecid L Cream, BAYB5097)Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| Clotrimazole 1% (Empecid L Cream, BAYB5097) | Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase. Receives: Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream.
Measured: Up to one month
Types of AE recorded in Questionnaire
Measured: Up to one month
Secondary outcomes (1)
Patterns and way of use of Empecid L Cream recorded in Questionnaire
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start10 Jul 2018
- Primary completion7 Jul 2021
- Study completion3 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal CandidaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SATO PHARMACEUTICAL , Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03599323
- Sponsor's protocol ID
- 19439
- Status last verified
- Jul 2022
- First submitted
- 17 Jul 2018
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Post-marketing, Multi-center, Single-cohort, Safety (Questionnaire) Investigation of Empecid L Cream (Clotrimazole 1%)
- ClinicalTrials.gov ID
- NCT03599323
- Acronym / sponsor ID
- 19439
- Conditions
- Vaginal Candida
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- SATO PHARMACEUTICAL , Ltd.
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 3 Sep 2021 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clotrimazole 1% (Empecid L Cream, BAYB5097) | – | Drug: Clotrimazole 1% (Empecid L Cream, BAYB5097)Patients who self-selected Empecid L Cream, and who will have pharmacist intervention prior to purchase. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The primary population of interest is composed of subjects 15 years or older and under 60 years who purchase Empecid L Cream.
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clotrimazole 1% (Empecid L Cream, BAYB5097)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). | Drug | Clotrimazole 1% (Empecid L Cream, BAYB5097) |
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
1 secondary outcome
Patterns and way of use of Empecid L Cream recorded in Questionnaire
Time frame: Up to one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginal Candida, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse event (AE) and serious adverse event (SAE) in consumers using Empecid L Cream. (time frame: Up to one month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2022.