Acne VulgarisNCT02349399
Drug Utilization Study on Diane-35 (and Generics) in Three European Healthcare Databases
An observational study of Acne Vulgaris, run by Bayer at 3 sites in 3 countries.
Trial summary
The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics
- How many people
- 26,065 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 May 2015to 1 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 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who are new users of CPA/EE in 2011/2012 and in 2014
Who may be able to join
- The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of ≥ 365 days prior to index date will be included in the study.
Who cannot join
- <365 days recorded history in the database prior to index date
- a prescription of CPA/EE in the year prior to index date
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Drug Utilization Study on Diane®-35 (and Generics) in European Healthcare Databases
The study objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
- Conditions
- Acne Vulgaris
- Being tested
- Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics
- 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 / Ethinylestradiol (Diane-35, BAY86-5264) and its GenericsDrug
Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg
| Study group | Role | What they receive |
|---|---|---|
| Drug Utilisation / Cohort 1 | New users of CPA/EE in 2011/2012 and in 2014 Receives: Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
Measured: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism
Measured: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)
Measured: up to 12 months
Secondary outcomes (2)
Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.
Measured: up to 12 months
Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Mar 2016
- Study completion1 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 26,065 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02349399
- Sponsor's protocol ID
- 17660
- Other IDs
- DI1402
- Status last verified
- Apr 2017
- First submitted
- 23 Jan 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
- Drug Utilization Study on Diane®-35 (and Generics) in European Healthcare Databases
- ClinicalTrials.gov ID
- NCT02349399
- Acronym / sponsor ID
- 17660
- Conditions
- Acne Vulgaris
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26,065 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Mar 2016 (actual)
- Study completion
- 1 Mar 2016 (actual)
- First posted
- 28 Jan 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 objectives are to characterize new users of Cyproterone Acetate / Ethinylestradiol (CPA/EE) in 2011/2012 and in 2014 according to demographics, treatment characteristics, previous diagnosis of acne, hirsutism or other hyperandrogenic conditions, previous acne treatment and (concomitant) use of hormonal contraceptives identified in Healthcare Databases in the UK (THIN), the Netherlands (PHARMO) and Italy (HSD).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drug Utilisation / Cohort 1 | – | Drug: Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its GenericsNew users of CPA/EE in 2011/2012 and in 2014 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who are new users of CPA/EE in 2011/2012 and in 2014
Key inclusion criteria (1 listed)
- The study population will include all female patients registered in the investigated healthcare databases receiving CPA/EE in 2011 or 2012 (first run) or 2014 (second run), without a prescription of CPA/EE in the year prior to index date. Only patients with recorded history in the database of ≥ 365 days prior to index date will be included in the study.
Key exclusion criteria (2 listed)
- <365 days recorded history in the database prior to index date
- a prescription of CPA/EE in the year prior to index date
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 / Ethinylestradiol (Diane-35, BAY86-5264) and its GenericsHormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg | Drug | Drug Utilisation / Cohort 1 |
Primary outcome
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne
Time frame: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Hirsutism
Time frame: up to 12 months
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of other Hyperandrogenic Conditions (e.g. androgenic alopecia, seborrhea, polycystic ovary syndrome)
Time frame: up to 12 months
2 secondary outcomes
Determination of previous acne treatments (prescription drugs only) of Diane-35 (or generics) users with a previous diagnosis of acne.
Time frame: up to 12 months
Proportion (%) of new Diane-35 (or generics) users, who have concomitant prescriptions of other combined oral contraceptives
Time frame: up to 12 months
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
3 sites in 3 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 3 sites in 3 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 2 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 3 sites in Italy, Netherlands, United Kingdom. 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?
Proportion (%) of new users of Diane-35 (or generics) with a previous diagnosis of Acne (time frame: up to 12 months). The study lists 3 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 5 Apr 2017.