The risk of developing prostate cancer in entacapone and levodopa/DDCI users compared to levodopa/DDCI users without entacapone - A nation-wide retrospective register-based study

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/14806
• EU PAS number:
  EUPAS2612
• Study ID:
  14806
• Official title and acronym:
  The risk of developing prostate cancer in entacapone and levodopa/DDCI users compared to levodopa/DDCI users without entacapone - A nation-wide retrospective register-based study
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  The purpose of the study is to evaluate whether treatment with entacapone as add-on to levodopa/DDCI increases the risk of developing prostate cancer when comparing to treatment without entacapone as add-on to levodopa/DDCI among male PD patients in Finland.
• Study status:
  Finalised

Research institution and networks

Institutions

EPID Research Oy

Study timelines

Date when funding contract was signed

Planned: 01/02/2011

Actual: 21/02/2011

Study start date

Planned: 16/05/2011

Actual: 01/12/2011

Date of final study report

Planned: 31/10/2012

Actual: 25/06/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Orion Corporation Orion Pharma

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)