Study identification

EU PAS number

EUPAS3712

Study ID

14169

Official title and acronym

Prescription patterns of combined hormonal contraceptives with 3rd or 4th versus 2nd generation progestogens in France, Germany and the UK during 2002- 2011: A retrospective analysis of the IMS Disease Analyser databases

DARWIN EU® study

No

Study countries

France
Germany
United Kingdom

Study description

The PRAC is currently reviewing under Article 31 of Directive 2001/83/EC the risk of venous and arterial thromboembolic events and risk minimisation in users of all formulations of 3rd or 4th generation combined hormonal contraceptives. In the context of such a review, a comparative description of prescribing patterns of these medicinal products versus 2nd generation combined hormonal contraceptives in three large EU countries over a 10 year period can further inform on drug utilisation and thereby support regulatory decision-making from a public health perspective. This study aims to describe the prescription of 3rd or 4th versus 2nd generation progestogen-containing combined hormonal contraceptives in France, Germany and the UK in the period 2002-2011. The study includes women 15 - 49 years old who are recipients of at least one prescription of combined hormonal contraceptives containing 2nd, 3rd or 4th generation progestogens as recorded during the study period from 1st January 2002 to 31st December 2011 in the IMS Disease Analyser data of France, Germany and the UK. In each study country the number and proportion of women being prescribed 3rd or 4th versus 2nd generation combined hormonal contraceptives are computed and stratified by age, time in calendar years, and by ‘new user’ versus ‘switcher’.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

Annalisa Rubino

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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