Table I.
Study and patient characteristics.
| Sample size, n | ||||||||
|---|---|---|---|---|---|---|---|---|
| First author, year (ref.) | Country | Ex | C | Inclusion criteria | Exclusion of PSA levels | Duration of intervention | Dosage and administration method | Main outcomes |
| Amory et al, 2004 (8) | USA | 24 | 24 | TT<350 ng/dl, Y>65 | >4.0 ng/ml | 36 months | 200 mg TE IM, every 2 weeks | Bone mineral density, prostate volume, PSA |
| Cavallini et al, 2004 (9) | Italy | 40 | 45 | FT<6 pg/ml Y>60, with symptoms of androgen decline | >4.0 ng/ml | 6 months | TU 160 mg/day, PO | PSA, prostate volume |
| Page et al, 2005 (10) | USA | 24 | 24 | TT<350 ng/dl, Y>65 | >4.0 ng/ml | 36 months | 200 mg TE IM, every 2 weeks | Weight, total cholesterol |
| Marks et al, 2006 (11) | USA | 21 | 19 | TT< 300 ng/dl, Y=44–78 with symptoms | 10.0 ng/ml | 6 months | 150 mg TE IM, every 2 weeks | IPSS, prostate volume, PSA |
| Vaughan et al, 2007 (12) | USA | 24 | 23 | TT<350 ng/dl, Y>65 | >4.0 ng/ml | 3 years | 200 mg TE IM, every 2 weeks | PSA, prostate volume |
| Emmelot-Vonk et al, 2008 (7) | Netherlands | 113 | 110 | TT<13.7 nmol/l Y=60–80 | Y=60–69, >4.5 µg/l Y>70, >6.5 µg/l | 6 months | 160 mg/day TU, PO | BMI, body weight, total cholesterol, total lean body mass, total fat mass, IPSS, BMD, adverse event, PSA, prostate volume |
| Aversa et al, 2010 (13) | Italy | 40 | 10 | TT<3.0 ng/ml, with metabolic syndrome, Y=45–65 | Age-adjusted elevated PSA | 24 months 12 weeks | 1,000 mg TU IM, every | BMI, total cholesterol |
| Aversa et al, 2010 (14) | Italy | 32 | 10 | TT<3.20 ng/ml, with metabolic syndrome, Y=50–65 | Age-adjusted elevated PSA | 12 months | 1,000 mg TU IM, every 12 weeks | BMI, total cholesterol, AMS score, IPSS, prostate volume |
| Idan et al, 2010 (15) | USA | 55 | 55 | Healthy, Y>50 | >4.0 g/l | 24 months | 70 mg DHT daily, transdermal | BMI, total cholesterol, prostate volume, IPSS, PSA, mild to moderate adverse event, total lean body mass, BMD |
| Kalinchenko et al, 2010 (16) | Russia | 105 | 65 | TT<12.0 nM, with metabolic syndrome, Y=35–70 | >4.0 g/l | 30 weeks | 1,000 mg TU IM, every every 12 weeks | BMI, body weight, total cholesterol, IPSS, prostate volume, PSA |
| Srinivas-Shankar et al, 2010 (17) | New Zealand | 130 | 132 | TT<345 ng/dl, presence of frailty, Y>65 | >4.0 g/l | 6 months | 50 mg/day testosterone gel, transdermal | AMS score, total lean body mass, total fat mass, total cholesterol, IPSS, PSA, mild to moderate adverse event, serious adverse event |
| Kaufman et al, 2011 (18) | USA | 234 | 40 | TT<300 ng/dl, Y=18.80 | >2.5 g/l | 6 months | 1.62% testosterone gel, serum total testosterone | Mild.to.moderate adverse event, serious adverse event |
| Shigehara et al, 2011 (19) | Japan | 23 | 23 | TT<11.8 pg/ml, with BPH | >2.0 g/l | 12 months | 250 mg TE IM, every 4 weeks | AMS score, IPSS, PSA |
| Behre et al, 2012 (6) | Germany | 183 | 179 | TT<15 nmol/l, Y=50.80 with symptoms of testosterone deficiency | >4.0 g/l | 6 months | Hydroalcoholic 1% testosterone gel (50 mg) daily, transdermal | AMS score, BMD, PSA, total lean body mass, total fat mass, bone mass, body weight serious adverse event |
| Frederiksen et al, 2012 (20) | Denmark | 20 | 18 | TT<7.3 nmol/l, Y=60.78 | >3.0 g/l | 6 months | Hydroalcoholic 1% testosterone gel (50 mg) daily, transdermal | BMI, body weight, total cholesterol, total lean body mass, total fat mass, PSA |
| Ho et al, 2012 (21) | Malaysia | 60 | 60 | TT>12 nmol/l, Y>40 | >4.0 g/l | 12 months | 1,000 mg TU IM, every 12 weeks | AMS score, serious adverse event, mild to moderate adverse event |
Ex, experimental; C, control; PSA, prostate-specific antigen; TT, total testosterone; FT, free testosterone; Y, age in years; TE, testosterone enanthate; IM, intramuscularly; TU, testosterone undecenoate; PO, per os; IPSS, International Prostate Symptom Score; AMS, Aging Male Symptom; DHT, dihydrotestosterone; BMI, body mass index; BMD, bone mineral density.