Study identification

PURI

https://redirect.ema.europa.eu/resource/40853

EU PAS number

EUPAS21352

Study ID

40853

Official title and acronym

Study of utilisation of combined hormonal contraceptives in Europe

DARWIN EU® study

No

Study countries

Denmark
Netherlands
United Kingdom

Study description

This study has the following objectives1. To investigate trends in new user (initiators) prescribingpatterns in the two years preceding the relevantCommission Decision (January 2012 – January 2014)and in a similar period following the decision (February2014– December 2015).2. To investigate switching patterns between productsamong prevalent users including reasons for changes(e.g., reimbursement or regulatory and clinicalguidance).3. Within Objectives 1 and 2, to examine any changes inutilisation in groups defined by patient’s clinical anddemographic risk factors for VTE as detailed in thewarnings and contraindications in the European UnionSummary of Product Characteristics (SmPC).4. To examine any differences in the incidence rates of VTEbetween the two periods specified and, in light of theresults for Objective 1-3, to investigate any measurableassociation between the observed changes in CHC useand changes in the VTE incidence rates.

Study status

Finalised
Research institution and networks

Institutions

University College London Leiden University, the Netherlands

Networks

Aarhus University Consortium (ad-hoc)

Contact details

Henrik Toft Sørensen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

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

Study of utilisation of combined hormonal contraceptives in Europe

English (393.15 KB - 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