Status: Finalised First registered on: 17/08/2012
Last updated on: 25/08/2017
1. Study identification
EU PAS Register NumberEUPAS2738
Official titlePatterns and Determinants of Use of Oral Contraceptives in the European Union
Study title acronymUse of OC in the EU
Study typeObservational study
Brief description of the studyThe study aims to set the basis for future safety evaluations of oral contraceptive use in Europe, by assessing current user and treatment characteristics in daily practice in five European databases from the Netherlands, UK and Italy, capturing a source population of 25 million individuals. Specific study objectives are to assess among women using oral contraceptive in 2009 and 2010 in different countries in Europe: prevalence and incidence estimates, demographics, health indicators and morbidity and OC treatment characteristics.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsErasmus MC Pharmacoepi
Department/Research groupPharmacoepidemiology Erasmus University
Organisation/affiliationErasmus University Medical Center
Website/Homepagewww.erasmusmc.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
EU-ADR Alliance
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

PHARMO Institute
Synapse Research Management Partners, S.L., Barcelona, Spain
Agenzia regionale di sanità della Toscana, Firenze, Italy
Università degli Studi di Milano-Bicocca, Milano, Italy
EMC Rotterdam, Dept of Medical Informatics, Rotterdam, the Netherlands
Countries in which this study is being conducted
International study

Italy
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/12/2011
Start date of data collection22/08/201220/08/2012
Start date of data analysis22/08/201220/08/2012
Date of interim report, if expected25/10/201225/10/2012
Date of final study report02/01/201317/01/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherEMA100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Verhamme
First name Katia
Address line 1EMC Rotterdam, Dept of Medical Informatics
Address line 2Dr Molewaterplein 50 
Address line 3 
CityRotterdam 
Postcode3015 GE 
CountryNetherlands
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address irene.bezemer@pharmo.nl
Public Enquiries
Title Dr 
Last name Verhamme 
First name Katia 
Address line 1EMC Rotterdam, Dept of Medical Informatics 
Address line 2Dr Molewaterplein 50 
Address line 3 
CityRotterdam 
Postcode3015 GE 
CountryNetherlands 
Phone number (incl. country code)31107043050 
Alternative phone number 
Fax number (incl. country code) 
Email address irene.bezemer@pharmo.nl 
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