Status: Finalised First registered on: 22/10/2017
Last updated on: 03/05/2021
1. Study identification
EU PAS Register NumberEUPAS21352
Official titleStudy of utilisation of combined hormonal contraceptives in Europe
Study title acronym
Study typeObservational study
Brief description of the studyThis study has the following objectives 1. To investigate trends in new user (initiators) prescribing patterns in the two years preceding the relevant Commission Decision (January 2012 – January 2014) and in a similar period following the decision (February 2014– December 2015). 2. To investigate switching patterns between products among prevalent users including reasons for changes (e.g., reimbursement or regulatory and clinical guidance). 3. Within Objectives 1 and 2, to examine any changes in utilisation in groups defined by patient’s clinical and demographic risk factors for VTE as detailed in the warnings and contraindications in the European Union Summary of Product Characteristics (SmPC). 4. To examine any differences in the incidence rates of VTE between the two periods specified and, in light of the results for Objective 1-3, to investigate any measurable association between the observed changes in CHC use and changes in the VTE incidence rates.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
Aarhus University Consortium (ad-hoc)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?3
University College London, Leiden University, the Netherlands
Countries in which this study is being conducted
International study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
Date when funding contract was signed23/11/201623/11/2016
Start date of data collection30/11/201730/11/2017
Start date of data analysis
Date of interim report, if expected01/08/201801/08/2018
Date of final study report14/11/201803/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Government body
Research councils
EU funding schemeEuropean Medicines Agency100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Ehrenstein
First name Vera
Address line 1Department of Clinical Epidemiology
Address line 2Olof Palmes Alle 43-45 
Address line 3 
CityAarhus N 
Phone number (incl. country code)45-87167212 
Alternative phone number 
Fax number (incl. country code) 
Email address
Public Enquiries
Title Professor 
Last name Sørensen 
First name Henrik Toft 
Address line 1Olof Palmes Allé 43-45 
Address line 2 
Address line 3 
CityAarhus N 
Phone number (incl. country code)45-87167212 
Alternative phone number 
Fax number (incl. country code) 
Email address