Testosterone Replacement Therapy (TRT) and Risk of Acute Myocardial Infarction (AMI): An Administrative Healthcare Claims Study (F1D-MC-B006)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13304
• EU PAS number:
  EUPAS9151
• Study ID:
  13304
• Official title and acronym:
  Testosterone Replacement Therapy (TRT) and Risk of Acute Myocardial Infarction (AMI): An Administrative Healthcare Claims Study (F1D-MC-B006)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Several recent studies reported a higher risk of acute myocardial infarction (AMI) in patients treated with TRT. However, these studies were inconclusive due to concerns over the study design. Thus, the association between TRT and AMI risk is not clearly understood. This study proposes to investigate whether there is an association between TRT and AMI. Specifically the objectives are as following:Primary objective: To evaluate the incidence of AMI among patients treated with TRT relative to propensity score matched untreated hypogonal patients.Secondary objectives: To evaluate the incidence of AMI among patients treated with TRT relative to propensity score matched PDE5i treated patients.
• Study status:
  Finalised

Study timelines

Date when funding contract was signed

Planned: 15/04/2015

Actual: 15/04/2015

Study start date

Planned: 16/04/2015

Actual: 16/04/2015

Date of final study report

Planned: 29/01/2016

Actual: 31/03/2016

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

B006 PASS

Regulatory

• Was the study required by a regulatory body?:
  No