Association Between Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism: A Retrospective Cohort Study of the Veterans Administration Database

Chest. 2016 Sep;150(3):563-71. doi: 10.1016/j.chest.2016.05.007. Epub 2016 May 12.


Background: Testosterone replacement therapy (TRT) prescriptions have increased several-fold in the last decade. There have been concerns regarding a possible increased incidence of DVT and pulmonary embolism (PE) with TRT. Few data support the association between TRT and DVT/PE. We evaluated the incidence of DVT and PE in men who were prescribed TRT for low serum total testosterone (sTT) levels.

Methods: This is a retrospective cohort study, conducted using data obtained from the Veterans Affairs Informatics and Computing Infrastructure. We compared the incidence of DVT/PE between those who received TRT and subsequently had normal on-treatment sTT levels (Gp1), those who received TRT but continued to have low on-treatment sTT (Gp2), and those who did not receive TRT (Gp3). Those with prior history of DVT/PE, cancer, hypercoagulable state, and chronic anticoagulation were excluded.

Results: The final cohort consisted of 71,407 subjects with low baseline sTT. Of these, 10,854 did not receive TRT (Gp3) and 60,553 received TRT. Of those who received TRT, 38,362 achieved normal sTT (Gp1) while 22,191 continued to have low sTT (Gp2). The incidence of DVT/PE was 0.5%, 0.4%, and 0.4% in Gp1, Gp2, and Gp3, respectively. Univariate, multivariate, and stabilized inverse probability of treatment weights analyses showed no statistically significant difference in DVT/PE-free survival between the various groups.

Conclusions: This study did not detect a significant association between testosterone replacement therapy and risk of DVT/PE in adult men with low sTT who were at low to moderate baseline risk of DVT/PE.

Keywords: DVT; pulmonary embolism; testosterone replacement therapy.

Publication types

  • Research Support, Non-U.S. Gov't
  • Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

  • Aged
  • Androgens / therapeutic use*
  • Cohort Studies
  • Databases, Factual
  • Hormone Replacement Therapy
  • Humans
  • Hypogonadism / drug therapy*
  • Incidence
  • Male
  • Middle Aged
  • Multivariate Analysis
  • Pulmonary Embolism / epidemiology*
  • Retrospective Studies
  • Testosterone / therapeutic use*
  • Treatment Outcome
  • United States
  • United States Department of Veterans Affairs
  • Venous Thrombosis / epidemiology*
  • Veterans


  • Androgens
  • Testosterone