Finasteride and male breast cancer – a register-based nested case-control study in Denmark, Finland, Norway, and Sweden (MK-0906-162)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/25923
• EU PAS number:
  EUPAS17620
• Study ID:
  25923
• Official title and acronym:
  Finasteride and male breast cancer – a register-based nested case-control study in Denmark, Finland, Norway, and Sweden (MK-0906-162)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  Finland

  Norway

  Sweden
• Study description:
  The objective of this study is to investigate the potential association between finasteride (MK-0906) exposure and the development of breast cancer in men residing in Denmark, Sweden, Finland, and Norway from data in national registries. The primary hypothesis of this study is that the previously reported increased incidence of male breast cancer among finasteride users is explained by confounding factors.
• Study status:
  Finalised

Research institutions and networks

Institutions

Department of Epidemiology, Institute of Applied Economics and Health Research (ApHER)

Denmark

Study timelines

Date when funding contract was signed

Actual: 01/05/2011

Study start date

Actual: 01/05/2011

Data analysis start date

Planned: 30/11/2017

Actual: 30/11/2017

Date of final study report

Planned: 30/06/2018

Actual: 02/05/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck Sharp & Dohme Corp.

Study protocol

Initial protocol

0906-162 protocol_final-redaction

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)

Other study registration identification numbers and links

Study number: MK-0906-162NCT number: NCT01703520