Conclusions Oral TRT produces significant CV risk .
Differences in the degree to which serum DHT is elevated may underlie the varying CV risk by TRT administration route , as elevated serum dihydrotestosterone has been shown to be associated with CV risk in observational studies
Background Potential cardiovascular ( CV ) risks of testosterone replacement therapy ( TRT ) are currently a topic of intense interest .
However , no studies have addressed CV risk as a function of the route of administration of TRT .
Efficacy and safety of a new testosterone-in-adhesive matrix patch applied every 2 days for 1 year to hypogonadal men
OBJECTIVES To study long-term efficacy and safety of a testosterone-in-adhesive matrix patch , delivering 4.8 mg of testosterone daily . METHODS R and omized , open label , multicenter 1-year study . 224 hypogonadal patients were included . 188 received 2 patches  of 60 cm2 every 48 h and 36 patients had IM testosterone enanthate injection every 3 weeks . T , bioavailable T ( BT ) , DHT , E2 , LH , FSH and SHBG and clinical symptom scores ( AMS and MSF-4 ) were assessed at 3 , 6 and 12 months . RESULTS In the patch group , T serum levels were above 3 ng/mL in 85 % of patients and remained stable over time . BT , DHT and E2 levels were restored within physiological range . BT/T ratio varied from 20 to 70 % . In the IM group , the percentages of " normalized " patients appeared to be lower , although the two groups can not be adequately compared due to the kinetic profile of T following IM administration , result ing in greater variations of serum T levels , blood samplings occurring r and omly at time of peak , trough , or in between . A significant correlation was found between T , BT and the MSF-4 changes . BT levels were significantly related to total AMS score . PSA values showed a mean ( S.D. ) increase of 0.13 ( 0.38 ) , 0.23 ( 0.79 ) and 0.30 (1.47)ng/mL at weeks 14 , 27 and 53 , respectively . The patch was well tolerated with no negative impact either on lipid profile , or red blood cells . Administration site reactions occurred in 35 patients ( 18.8 % ) . Adhesiveness was good ( > or=75 % ) in > 90 % patients over the 1 year application period . CONCLUSION Two 60 cm2 patches , allowed constant physiological levels of sexual hormones over time . This new patch was well tolerated , easy to use , well accepted by the patients and displayed a very good adhesiveness . Clinical efficacy was more related to BT than to
Conclusions Oral TRT produces significant CV risk .
Differences in the degree to which serum DHT is elevated may underlie the varying CV risk by TRT administration route , as elevated serum dihydrotestosterone has been shown to be associated with CV risk in observational studies
Background Potential cardiovascular ( CV ) risks of testosterone replacement therapy ( TRT ) are currently a topic of intense interest .
However , no studies have addressed CV risk as a function of the route of administration of TRT .