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

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