Status: Finalised First registered on: 23/01/2015
Last updated on: 26/08/2019
1. Study identification
EU PAS Register NumberEUPAS8412
Official titleDrug Utilization Study on Diane®-35 (and generics) in European healthcare databases
Study title acronym
Study typeObservational study
Brief description of the studyThe 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).
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 1 (imposed as condition of marketing authorisation)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsPHARMO Institute
Department/Research group
Organisation/affiliationThe PHARMO Institute for Drug Outcomes Research
Website/Homepagewww.pharmo.nl
Details of (Primary) lead investigator
Title Dr
Last name Bayer HealthCare AG
First name CTP Team / Ref: "ENCePP"/ Bayer Pharma AG
Is this study being carried out with the collaboration of a research network?
Yes
- PHARMO: Database Network , Netherlands
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3

CEIFE
Italy, HIS: The Health Search institute
Countries in which this study is being conducted
International study

Italy
Netherlands
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/12/2014
Start date of data collection01/02/201501/05/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report30/01/201631/03/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBayer100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Bayer HealthCare AG
First name CTP Team / Ref: "ENCePP"/ Bayer Pharma AG
Address line 1Müllerstraße 178
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayerhealthcare.com
Public Enquiries
Title Dr 
Last name Bayer HealthCare AG 
First name CTP Team / Ref: "ENCePP"/ Bayer Pharma AG 
Address line 1Müllerstraße 178 
Address line 2 
Address line 3 
CityBerlin 
Postcode13342 
CountryGermany 
Phone number (incl. country code)49-30300139005 
Alternative phone number 
Fax number (incl. country code) 
Email address clinical-trials-contact@bayerhealthcare.com 
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