Table 1. Characteristics and outcomes of the randomized clinical studies included in the meta-analysis.
| Variable | Study | |||||
|---|---|---|---|---|---|---|
| Rosano et al (1999) [11] | Webb et al (1999) [12] | English et al (2000) [13] | Thompson et al (2002) [14] | Malkin et al (2004) [15] | Mathur et al (2009) [16] | |
| Drug | T (iv) | T (iv) | T patch | T (iv) | Sustanon (im) | TU (im) |
| Dose | 2.5 mg once | 2.3 µg once | 5 mg daily | a | 100 mg twice/week | 1,000 mg/12 weeks |
| Comparator | Placebo | Placebo | Placebo | Placebo | Placebo | Placebo |
| Randomization | A | A | A | A | A | A |
| Blinding | A | A | A | A | A | A |
| Drop-out | A | A | A | A | A | A |
| Intention-to-treat | Yes | Yes | Yes | Yes | Yes | Yes |
| No. of patients (ID/C) | 7/7 | 14/14 | 22/24 | 34/34 | 10/10 | 7/6 |
| Trial duration (wk) | - | - | 14 | - | 4 | 52 |
| Age (yr) | 58 | 57 | 62 | 69.1 | 60.8 | 64.8 |
| TT baseline (nmol/L) | NA | 5.3 | 12.9 | NA | 4.2 | 9.9 |
| DM baseline (%) | 7.1 | 21.4 | 15.3 | NA | 50 | 23.1 |
| MI baseline (%) | 35.7 | 50 | 10.9 | 32 | 30 | 30.8 |
| Exercise duration endpoint (second ID/C) | 631.0±180.0/541.0±204.0 | NA | NA | NA | NA | 463.6±46.2/363.3±143.5 |
| Time to 1-mm ST depression endpoint (second ID/C) | 579.0±204.0/471.0±210.0 | 364.0±149.7/298.0±127.2 | 361.0±103.2/292.0±117.6 | 294.0±132.0/288.0±132.0 | 399.0±84.0/352.0±150.0 | 449.0±67.5/262.7±110.3 |
| 288.0±138.0a/288.0±132.0a | ||||||
Values are presented as number or mean±standard deviation.
ID/C: investigational drug/comparator, TT: total testosterone, DM: diabetes mellitus, MI: myocardial infarction, T: testosterone, iv: intravenous, im: intramuscular, TU: testosterone undecanoate in castor oil, A: adequate, NA: not available.
aTestosterone doses were individualized to produce physiologic (defined as double the baseline testosterone level) or supra-physiologic (6× baseline) serum testosterone levels.