Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/26587
• EU PAS number:
  EUPAS21356
• Study ID:
  26587
• Official title and acronym:
  Study of regulatory communication and risk awareness following the Article 31 referral of Combined Hormonal Contraceptives in relation to thromboembolism
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Slovakia

  Spain

  United Kingdom
• Study description:
  This 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
• Study status:
  Finalised

Research institution and networks

Institutions

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

Aarhus University & Aarhus University Hospital DEPARTMENT OF CLINICAL EPIDEMIOLOGY

Denmark

University College London United Kingdom

Networks

Aarhus University Consotrium (ad hoc)

Contact details

Vera Ehrenstein

Study contact

[e-mail]

Henrik Toft Sørensen

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned: 21/06/2016

Actual: 21/06/2016

Data collection

Planned: 30/01/2017

Actual: 30/01/2017

Date of final study report

Planned: 23/01/2018

Actual: 07/02/2018

Sources of funding

EMA

Study protocol

Initial protocol

Study of regulatory communication and risk awareness

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable