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Table 1 Characteristics of placebo-controlled randomized trials giving the effects of testosterone therapy on cardiovascular-related events among men

From: Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials

Author and publication year

Study

Participants

Industry funding

 

Setting

Duration

Dose

Cardiovascular-related events based on

Age range

Number

Health status

Initial T (nmol/L)

 

Copenhagen Study Group [49] 1986

Denmark

About 16 monthsa

200 mg/8 h micronized T, PO

Deaths

24 to 79

221

alcoholic cirrhosis

about 20

None given

Marin [39] 1993

Denmark

9 months

T gel 125 mg/day

Withdrawals

40 to 65

21

Obese, low T

15.3

Funded by Besins Iscovesco

Hall [51] 1996

UK

9 months

T enanthate 250 mg /month, IM

Withdrawals

34 to 79

35

Rheumatoid arthritis

16.1

Funded by Schering Healthcare

Sih [52] 1997

US

12 weeks

T cypionate IM every 14 to 17 days

Withdrawals

51 to 79

32

T<60 ng/dl

9.2

None given

English [53] 2000

UK

12 weeks

Transdermal T 5 mg/day

Withdrawals and safety data

Mean 62

50

Coronary artery disease

12.9

Patches given by Smith Kline Beecham

Snyder [19] 2001

US

36 months

Transdermal T 6 mg/day

Clinically apparent from hospital records

65+

108

Men with T one SD <475 ng/dl

12.7

Patches given by ALZA Corporation

Amory [54] 2004

US

36 months

T enanthate 200 mg/2 weeks, IM

Serious adverse cardiovascular events

65 to 83

48

TT <350 ng/dl

10

None given

Kenny [55] 2004

US

12 weeks

T enanthate 200 mg/3 weeks, IM

General description

73 to 87

11

Cognitive decline, bioavailable T <128 ng/dl

14.1

None

Svartberg [56] 2004

Norway

26 weeks

T enanthate 250 mg/month, IM

General description

Mean 66

29

COPD

21.1

None

Brockenbrough [57] 2006

US

6 months

Transdermal T gel 10 g/day

Side effects and adverse events

Mean 56

40

Dialysis and TT <300 ng/dl

7.3

Supported by Auxilium Pharmaceuticals

Malkin [58] 2006

UK

12 months

Transdermal T patch 5 mg/day

Serious adverse events

Mean 64

76

Heart failure

13.0

Medication given by Watson Pharmaceuticals

Merza [59] 2006

UK

6 months

Transdermal T patch 5 mg/day

Withdrawals

40+

39

TT <10 nmol/L

8.0

Supported by Ferring Pharmaceuticals Ltd

Nair [60] 2006

US

24 months

Transdermal T patch 5 mg/day

Adverse events

60+

62

DHEA<1.57 μg/ml, bioavailable T <103 ng/dl

13.7

Supported by The Endocrine Society

Emmelot-Vonk [61] 2008

Netherlands

6 months

TU 160 mg/day, PO

Adverse events

60 to 80

237

TT<13.7 nmol/L

10.7

Medication given by Organon NV

Svartberg [41] 2008

Norway

52 weeks

TU 1000 mg, MI at 0, 6, 16, 28 and 40 weeks

Deaths

60 to 80

38

TT≤11.0 nmol/L

8.3

Grant from Bayer Schering Pharma AG

Caminiti [62] 2009

Italy

12 weeks

TU 1000 mg MI for 0, 6 and 12 weeks

General description of events

66 to 76

70

Heart failure

7.0

None given

Chapman [48] 2009

Australia

1 year

TU 80 mg orally twice a day

Hospitalizations

65+

23

Undernourished

18.8

Organon provided funding

Legros [46] 2009

Europe

1 year

TU 80, 160 and 240 mg orally per day

Safety assessments

50+

316

Free T<0.26 nmol/L

12.8

Funded by Schering-Plough

Aversa [63] 2010

Italy

24 months

TU 1,000 mg (every 12 weeks)

Safety aspects

45 to 65

50

MS and/or T2DM TT<3.0 ng/ml

8.5

None given

Basaria [50] 2010

US

About 6 monthsa

Transdermal T gel 100 mg/day

Cardiovascular-related events

65+

209

Frial, TT 100 to 350 ng/dl

8.4

Medication given by Auxilium Pharmaceuticals

Srinivas-Shankar [64] 2010

US

6 months

Transdermal T gel 50 mg/day

Serious adverse events and withdrawals

65+

274

TT≤12 nmol/L (345 ng/dl)

11.0

Supported by Bayer Schering Pharma

Jones [65] 2011

Europe

12 months

T gel 60 mg/day

Cardiovascular events

37 to 88

220

Hypogonadal with type 2 diabetes and/or MetS,

9.4

Supported by ProStrakan

Ho 2011 [66]

Malaysia

1 year

TU 1000 mg MI for 0, 6, 18, 30 and 42 weeks

Withdrawals

40+

120

T<12 nmol/L,

9.0

Supported by Bayer Schering Pharma

Kaufman [44] 2011

US

182 days

1.62% T gel 2.5 mg/day

Safety aspects

45 to 64

274

Hypogonadal, T<300 ng/dl

9.8

Funded by Abbott.

Kalinchenko [67] 2010

Russia

30 weeks

TU 1,000 mg MI for 0, 6, 18 and 30 weeks

Withdrawal

35 to 70

184

T<350 ng/dl

7.0

Supported by Bayer Schering Pharma

Hoyos [68] 2012

Australia

18 weeks

TU 1000 mg MI at 0, 6 and 12 weeks

Adverse events

18+, mean 49

67

Obese men with obstructive sleep apnea

13.3

Supported by Bayer Schering Pharma

Spitzer [26] 2012

US

14 weeks

1% T gel 10 g/day

Adverse events

40 to 70

140

Erectile dysfunction low T and a sexual partner

12.3

none

  1. atrial stopped early so duration varies. IM= intramuscularly; P, placebo; PO, orally; T= testosterone; TT= total testosterone; TU= testosterone undecanoate.