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Table 1 Characteristics of placebo-controlled randomized clinical trials of testosterone replacement therapy (TRT) reporting CV events

From: Cardiovascular risks and elevation of serum DHT vary by route of testosterone administration: a systematic review and meta-analysis

Author/Year Mode Dose Study duration Age Subjects in TRT group Subjects in placebo group Serum T at entry Health status
Amory 2004 [32] i.m. 100 mg TE/week 36 months 71 ± 4 (SD) 24 24 302 ± 48 (SD) ng/dL hypogonadal
Aversa 2010 [33] i.m. 1,000 mg TU/12 week 24 months 58 ± 10 (SD) 40 10 259 ± 48 (SD) ng/dL hypogonadal
Borst 2014 [34] i.m. 125 mg TE/week 12 months 69.2 ± 8.0 (SD) 31 29 264 ± 92 (SD) ng/dL hypogonadal
Caminiti 2009 [35] i.m. 1,000 mg TU/8 week 4.5 months 66 to 76 35 35 230 ± 180 (SD) ng/dL hypogonadal, heart failure
Ferrando 2002 [36] i.m. 100 mg TE/week 6 months 67 ± 3 (SD) 7 5 <480 ng/dL eugonadal
Hackett 2014 [37] i.m. 1000 mg TU/6 to 12 weeks 7.5 months 18 to 80 97 102 301 ± 11 (SD) ng/dL hypogonadal, type 2 diabetes
Hall 1996 [38] i.m. 250 mg TE/4 weeks 9 months 60.8 ± 9.7 (SD) 17 18 458 ± 187 (SD) ng/dL eugonadal, rheumatoid arthritis
Ho 2011 [39] i.m. 1,000 mg TU/10 to 14 weeks 24 months ≥40 60 60 <345 ng/dL low normal T
Hoyos 2012 [40] i.m. 1,000 mg TU/6 weeks 4.5 months 49 ± 12 (SD) 33 34 388 ± 152 (SD) ng/dL eugonadal, obese, sleep apnea
Kalichenko 2010 [41] i.m. 1,000 mg TU/6 to 12 weeks 7.5 months 49 to 53 113 71 <345 ng/dL low normal T, metabolic syndrome
Kenny 2004 [42] i.m. 200 mg TE/3 weeks 3 months 81 ± 5 (SD) 6 5 410 ± 112 (SD) ng/dL mild cognitive impairment
Sih 1997 [43] i.m. 200 mg TC/2 weeks 12 months 65 ± 7 (SD) 17 15 233 ± 20 (SD) ng/dL hypogonadal
Svartberg 2004 [44] i.m. 250 mg TE/4 weeks 6 months 64 ± 6.5 (SD) 15 14 590 ± 164 (SD) ng/dL eugonadal, COPD
Svartberg 2008 [45] i.m. 1,000 mg TU/6 to 12 weeks 12 months 69 ± 5 (SD) 19 19 239 ± 54 (SD) ng/dL hypogonadal
Sheffield-Moore 2011 [46] i.m. 100 mg TE/week 5 months 73 ± 8 (SD) 8 8 <500 ng/dL eugonadal
Tan 2013 [47] i.m. 1,000 mg TU/8 weeks 12 months 53.8 ± 8.3 (SD) 56 58 <345 ng/dL low normal T
*Basaria 2010 [7] gel 100 to 150 mg T/day 6 months* 74 ± 5 (SD) 106 103 250 ± 57 (SD) ng/dL hypogonadal, mobility limited
Brockenbrough 2006 [48] gel 100 mg T/day 6 months 58.9 ± 14.9 (SD) 19 21 218 ± 64 (SD) ng/dL hypogonadal, renal disease
Glintborg 2013 [49] gel 50 to 100 mg T/day 6 months 62 to 72 20 18 <210 ng/dL hypogonadal, obese
Hildreth 2013 [50] gel 25 to 50 mg T/day 12 months 66.6 ± 5.8 (SD) 96 47 294 ± 38 (SD) ng/dL hypogonadal
Jones 2011 [51] gel 60 mg T/day 12 months 37 to 77 108 112 265 ± 75 (SD) ng/dL hypogonadal, metabolic syndrome
Kaufman 2011 [52] gel 20 to 80 mg T/day 6 months 53.6 ± 9.5 (SD) 234 40 mean =294 ng/dL hypogonadal
Kenny 2010 [53] gel 50 mg T/day 12 to 24 months 79.9 ± 7.3 (SD) 69 62 380 ± (SD) ng/dL eugonadal, osteoporosis
Marin 1993 [54] gel 125 mg T/day 9 months 56.7 ± 2.2 (SD) 11 10 434 ± 23 (SD) ng/dL eugonadal, obese
Spitzer 2012 [55] gel 100 to 300 mg T/day 3.5 months 55.1 ± 8.3 (SD) 70 70 248 ± 62 (SD) ng/dL hypogonadal, erectile dysfunction
Srinivas-Shankar 2010 [56] gel 50 mg T/day 6 months 73.7 ± 5.7 (SD) 138 136 313 ± 89 (SD) ng/dL low normal T, frail
English 2000 [17] patch 5 mg T/day 3 months 69 ± 2 (SD) 25 25 390 ± 22 (SD) ng/dL eugonadal, stable angina
Malkin 2006 [57] patch 5 mg T/day 12 months 63.1 ± 10.7 (SD) 37 39 400 ± 152 (SD) ng/dL eugonadal, heart failure
Merza 2005 [58] patch 5 mg T/day 6 months 63 ± 9 (SD) 20 19 242 ± 95 (SD) ng/dL hypogonadal
Nair 2006 [59] patch 5 mg T/day 24 months 61 to 72 27 31 bioavailable T <103 ng/dL hypogonadal
Snyder 2001 [60] patch 6 mg T/day 36 months 71.3 ± 5.8 (SD) 54 54 <475 ng/dL eugonadal
Chapman 2009 [61] oral 160 mg TU/day 12 months 78 ± 4 (SD) 11 12 541 ± 35 (SD) ng/dL eugonadal, undernourished
Copenhagen study 1986 [62]a oral 600 mg micronized T/day 8 to 62 months 24 to 79 134 87 not measured alcoholic cirrhosis
Emmelot-Vonk 2008 [63] oral 80 mg TU/day 6 months 67.1 ± 5.0 (SD) 120 117 316 ± 54 (SD) ng/dL low normal T
Legros 2009 [64] oral 80 to 240 mg TU/day 12 months 58.6 ± 5.7 (SD) 237 79 free T <7.5 ng/dL hypogonadal
  1. aStudy was stopped early. COPD. chronic obstructive pulmonary disease; i.m., intramuscular; SD, standard deviation; T, testosterone; TC, testosterone cypionate; TE, testosterone enanthate; TU, testosterone undecanoate.