Status: Finalised First registered on: 22/10/2017
Last updated on: 19/11/2018
1. Study identification
EU PAS Register NumberEUPAS21356
Official titleStudy of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism
Study title acronym
Study typeOther: Qualitative assessment
Brief description of the studyThis study uses surveys and questionnaires to study whether women and prescribers consider the risks of venous thromboembolism when making decisions about the use of combined hormonal contraceptives and what sources of information inform their assessments
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
Website/Homepagewww.kea.au.dk
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?
Yes
Aarhus University Consotrium (ad hoc)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?2

Aarhus University Dept. of Clinical Epidemiology
University College London, United Kingdom
Countries in which this study is being conducted
International study

Denmark
Slovakia
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed21/06/201621/06/2016
Start date of data collection30/01/201730/01/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report23/01/201807/02/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
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 2Aarhus University Hospital 
Address line 3 
CityAarhus 
Postcode 
CountryDenmark
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code) 
Email address ve@clin.au.dk
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 
Postcode8200 
CountryDenmark 
Phone number (incl. country code)45-87168063 
Alternative phone number 
Fax number (incl. country code)45-87167215 
Email address hts@clin.au.dk 
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