Acne VulgarisNCT02410031
Risk Minimisation Study for Diane-35 and Its Generics
An observational study of Acne Vulgaris, run by Bayer at 5 sites in 5 countries.
Trial summary
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
- How many people
- 759 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 26 Jun 2015to 4 Mar 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Physicians eligible to participate who have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Who may be able to join
- -Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Who cannot join
None listed.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.
Specifically, the following objectives will be addressed:
- Investigate whether physicians have received any educational material related to Diane-35 or its generics
- Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
- Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
- Contraindications relevant to thromboembolism
- Risk factors for thromboembolism
- Signs and symptoms of thromboembolism
- Conditions
- Acne Vulgaris
- Being tested
- Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)Drug
Cyproterone acetate 2mg/ethinylestradiol 35 μg
| Study group | Role | What they receive |
|---|---|---|
| Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35) | Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey Receives: Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The knowledge of the physician concerning Diane-35
The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist
Measured: Day1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2015 (estimated)
- Study start26 Jun 2015
- Primary completion4 Mar 2016
- Study completion4 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02410031
- Sponsor's protocol ID
- 17195
- Status last verified
- Apr 2017
- First submitted
- 2 Apr 2015
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Physician Knowledge of Safety and Safe Use Information for Diane-35 and Its Generics in Europe: An Observational Post-Authorisation Safety Study
- ClinicalTrials.gov ID
- NCT02410031
- Acronym / sponsor ID
- 17195
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- RTI Health Solutions
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 4 Mar 2016 (actual)
- Study completion
- 4 Mar 2016 (actual)
- First posted
- 7 Apr 2015 (estimated)
- 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.
The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians with recent experience in prescribing Diane-35 or its generics in a total of five European countries. The primary objective of this study is to measure physician knowledge and understanding of the key information contained in the Diane-35 educational material: Patient information card, and Prescribers' Checklist.
Specifically, the following objectives will be addressed:
- Investigate whether physicians have received any educational material related to Diane-35 or its generics
- Assess physicians' knowledge and understanding of key safety information pertaining to the patient information card
- Assess physicians' knowledge and understanding of key safety information pertaining to the following areas:
- Contraindications relevant to thromboembolism
- Risk factors for thromboembolism
- Signs and symptoms of thromboembolism
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35) | – | Drug: Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)Prescribers of Diane-35 who agree and fulfill the criteria inclusion to participate in the survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Physicians eligible to participate who have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Key inclusion criteria (1 listed)
- -Physicians eligible to participate will have recently prescribed (e.g., within previous 6 months) Diane-35 or its generics
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)Cyproterone acetate 2mg/ethinylestradiol 35 μg | Drug | Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35) |
Primary outcome
The knowledge of the physician concerning Diane-35
Time frame: Day1
The knowledge will be assessed based on a questionnaire with 22 questions which wil assess physician knowledge on key information contained in the Diane-35 educational material including patient information card, prescribers' checklist
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 5 Apr 2017.
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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.
Bayer Study Director study director
Bayer
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acne Vulgaris, run by Bayer at 5 sites in 5 countries.
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 0 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria, Czechia, France, Netherlands, Spain. 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?
The knowledge of the physician concerning Diane-35 (time frame: Day1). 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 5 Apr 2017.