The Risk of Venous Thrombotic Events among Males Treated with Testosterone Replacement Therapy (I5E-MC-B003)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/13309
• EU PAS number:
  EUPAS4894
• Study ID:
  13309
• Official title and acronym:
  The Risk of Venous Thrombotic Events among Males Treated with Testosterone Replacement Therapy (I5E-MC-B003)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Primary Objective: To evaluate the VTE risk using cohort study design by estimating the incidence rates (IRs), and hazard ratio (HR) of VTE among hypogonadal patients treated with testosterone replacement therapy (overall and by different routes of administration) relative to a propensity score matched untreated comparison groupSecondary Objective: To evaluate the VTE risk using a nested case-control study within original cohort by estimating the crude and adjusted odds ratio (OR) of VTE for patients exposed to testosterone products (overall and by different routes of administration) compared to untreated hypogonadal patientsStudy design: A retrospective cohort study is proposed as a primary study design, with a nested case-control study as a secondary study design. The retrospective cohort observational study will use electronic claims records in the United States (US) to assess the crude and adjusted incidence rate of VTE among patients newly treated with any testosterone products relative to hypogonadal patients without testosterone treatment matched on baseline characteristics and calendar time. A nested case-control study will be performed within the original hypogonadal cohort.
• Study status:
  Finalised

Research institutions and networks

Institutions

Eli Lilly and Company

Study timelines

Date when funding contract was signed

Planned: 04/10/2013

Actual: 15/02/2013

Study start date

Planned: 04/02/2014

Actual: 04/03/2014

Data analysis start date

Planned: 01/04/2014

Actual: 29/05/2014

Date of final study report

Planned: 30/09/2014

Actual: 23/10/2014

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Study protocol

Initial protocol

Axiron VTE study protocol_final Oc0413_submitted Enepp Feb 2014

Regulatory

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