Patterns and Determinants of Use of Oral Contraceptives in the European Union (Use of OC in the EU)

Study identification

• EU PAS number:
  EUPAS2738
• Study ID:
  20752
• Official title and acronym:
  Patterns and Determinants of Use of Oral Contraceptives in the European Union (Use of OC in the EU)
• DARWIN EU® study:
  No
• Study countries:
  Italy

  Netherlands

  United Kingdom
• Study description:
  The 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Erasmus Medical Centre Rotterdam

The PHARMO Institute for Drug Outcomes Research (PHARMO Institute)

Netherlands

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

Networks

EU-ADR Alliance

Study timelines

Date when funding contract was signed

Actual:02/12/2011

Study start date

Planned:22/08/2012

Actual:20/08/2012

Data analysis start date

Planned:22/08/2012

Actual:20/08/2012

Date of interim report, if expected

Planned:25/10/2012

Actual:25/10/2012

Date of final study report

Planned:02/01/2013

Actual:17/01/2013

Sources of funding

EMA

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable