Study identification

PURI

https://redirect.ema.europa.eu/resource/20752

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

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

Contact details

Miriam Sturkenboom

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
EMA
Study protocol
Initial protocol

D1.b_Final Study Protocol_v1.0 (OC)

English (1.07 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable