Presentation Authors: Jessica Wenzel*, Austin, TX, Luke Machen, Milwaukee, WI, Alex Ellis, Round Rock, TX, Mehraban Kavoussi, Dallas, TX, Keikhosrow Kavoussi, Shahryar Kavoussi, Parviz Kavoussi, Austin, TX
Introduction: Hypogonadism is estimated to effect between 2.1% and 12.8% of men. Current therapies to treat hypogonadism include testosterone replacement therapy (TRT) and Clomiphene Citrate (CC) as an off-label use. In June 2014, the US Food and Drug Administration mandated that manufacturers of all testosterone replacement therapy products add a label warning of increased risk of deep vein thrombosis (DVT) due to post market reports of increased DVT incidence in men on TRT. However, current literature supporting an increased risk of DVT with TRT usage is sparse. Although not designed for treatment of hypogonadism in men, the package insert for CC includes pulmonary embolism (PE), an end sequela of DVT. We sought to evaluate the risk of DVT in men treated with TRT or CC and to assess other etiologies for DVT as potential factors.
Methods: A retrospective chart review was performed of 1,180 consecutive men presenting for a hypogonadism evaluation who were treated with either TRT or CC.
Results: Of the 1,180 men with hypogonadism, 694 were treated with TRT, while 486 were treated with CC. Overall, 10/1180 (0.8%) men treated with TRT or CC were diagnosed with a DVT during the treatment interval. Of the 10 men diagnosed with DVT while on treatment, seven (70%) had potential identifiable etiologies for DVT other than treatment for hypogonadism. Etiologies included lower extremity trauma, surgery, travel, Klinefelter's syndrome, and Factor V Leiden deficiency. None of the men were found to be polycythemic at the time of DVT diagnosis. _x000D_
There was a higher incidence of DVT in men treated with TRT than CC; however, the overall percentages of DVT in both treatment groups were relatively low. When comparing the TRT and CC groups, there was no difference in the percentages of men found to have other identifiable etiologies for DVT besides being on treatment. There was no difference in testosterone levels between the TRT and CC groups.
Conclusions: The overall rates of DVT for TRT and CC treated patients at therapeutic levels are relatively low, and most patients with DVT had other identifiable etiologies for DVT. Polycythemia was not found to be a risk factor in the patients diagnosed with DVTs.