EMA study on prescribing of testosterone in the primary care setting

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14151
• EU PAS number:
  EUPAS6827
• Study ID:
  14151
• Official title and acronym:
  EMA study on prescribing of testosterone in the primary care setting
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  At its meeting 07–10 April 2014 the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) started a review of testosterone-containing medicines under Article 31 of Directive 2000/83/EC. The review was triggered by concerns about possible cardiac side effects of these medicines. The safety concerns were raised following the publication of a study suggesting that the use of testosterone increases the risk of myocardial infarction (heart attack) in men aged over 65 years, as well as in younger men with pre-existing heart disease. This study followed other studies including the Veterans Health Care Study, which suggests that men with pre-existing heart disease who received treatment with testosterone had a higher risk of heart problems than men who did not receive testosterone.The present study aims to describe the extent and patterns of prescription of testosterone in a primary care setting in the European Union in line with the scope of the Article 31 referral. This will be done using the EMA’s in-house IMS Health data. The primary objective of the study is to estimate the prevalence of testosterone use in males from 1990 to Q1 2013.Furthermore new users during the study period will be stratified according to recorded indication of use as well as dosage form prescribed. For the new users, co-morbidities at the time of the initial prescription will be determined based on prescription data using a validated method.
• Study status:
  Finalised

Research institutions and networks

Institutions

European Medicines Agency (EMA)

Study timelines

Date when funding contract was signed

Planned: 14/04/2014

Actual: 14/04/2014

Study start date

Planned: 01/05/2014

Actual: 01/05/2014

Date of final study report

Planned: 10/06/2014

Actual: 10/06/2014

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