Study of utilisation of combined hormonal contraceptives in Europe

Study identification

• 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 institutions and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

University College London Leiden University, the Netherlands

Networks

Aarhus University Consortium (ad-hoc)

Study timelines

Date when funding contract was signed

Planned:23/11/2016

Actual:23/11/2016

Study start date

Planned:30/11/2017

Actual:30/11/2017

Date of interim report, if expected

Planned:01/08/2018

Actual:01/08/2018

Date of final study report

Planned:14/11/2018

Actual:03/12/2018

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