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 |