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

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (G03BA03) testosterone

  testosterone
• Medical condition to be studied:
  Venous thrombosis

Population studied

• Short description of the study population:
  Male Hypogonadal patients aged 18 years or old with at least 12 months (365 days) of continuous enrollment in the health plan prior to the index date.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Hypogonadal patients
• Estimated number of subjects:
  3229

Study design details

• Main study objective:
  To evaluate the VTE risk using cohort study design by estimating the incidence rates (IRs), and hazard ratio (HR) of VTE among patients treated with testosterone replacement therapy (overall and by different routes of administration) relative to a propensity score matched untreated comparison group.
• Outcomes:
  According to the suggestion of FDA Mini-sentinel project, the following ICD-9 codes are used to define VTE : 415.x, 451.x, and 453.x. Three physicians will be adjundicating the claims of each case and dertermine if it is a idiopathic or non-idiopathic VTE case.
• Data analysis plan:
  Please provide a brief summary of the analysis method: The primary analysis of this protocol is to compare the percentage of patients who developed incident VTE after index date in treated patients who received at least 1 prescription of any testosterone products versus untreated patients who have not received any testosterone prescription. Propensity score matching method will be applied to select untreated cohort and match to treated cohort. Cox regression model will be used to estimate the incidence rate and hazard ratio. For the secondary (nested case-control) analysis, the conditional logistic regression is planned for univariate and multivariate analyses. The association between testosterone exposure patterns (current and past exposure of testosterone) will be reported as crude and adjusted OR representing the testosterone exposures relative to non-testosterone users.