Table 2.
Characteristics and outcomes of the controlled clinical studies included in the meta-analysis
| Study (ref.) |
# patients (T + PDE5i/ PDE5i ± placebo) |
Placebo controlled | PDE5i non responders | Trial duration (weeks) | Age (years) | T levels | Diabetes (%) |
Dose (daily) |
Design |
|---|---|---|---|---|---|---|---|---|---|
| Aversa et al. [86] | 10/10 | + | + | 4 | 48–66 | Mixed | 25 |
T patch 50 mg/day |
Parallel |
| Kalinchenko et al. [91] | 120/120 | - | + | 4 | 43–74 | <8 nM | 100 | TU 160 mg/day | BA |
| Foresta et al. [92] | 15/15 | - | - | 24 | 32.1 ± 2.6 | <8 nM | 0 | TG 50 mg/day | BA |
| Shabsigh et al. [93] | 39/36 | - | + | 12 | 18–80 | Mixed | 16 | TG 50 mg/day | Parallel |
| Shamloul et al. [94] | 10/10 | - | + | 8 | 40–70 | <8 nM | 0 | TU 120 mg/day | Parallel |
| Hwang et al. [95] | 32/21 | - | + | 12 | 23–73 | 12 nM | 12.5 |
TU 160–240 mg/day |
BA |
| Rochira et al. [96] | 24/24 | - | - | 24 | 35.0 ± 12.0 | <8 nM | 0 | TG 50 mg/day | Cross-Over |
| Garcia et al. [97] | 29/29 | - | + | 102 | 36–75 | <12 nM | NR | TU1000mg/12 weeks | BA |
| Buvat et al. [98] | 87/86 | + | + | 12 | 45–80 | Mixed | 32 | TG 50 mg/day | Parallel |
| Spitzer et al. [99] | 70/70 | + | - | 14 | 40–70 | <12 nM | 13.5 |
TG100 mg/day |
Parallel |
| Kim et al. [100] | 44/34 | - | + | 24 | 41–75 | <12 nM | 39 | TE 250 mg/month | BA |
| Hackett et al. [101] | 14/14 | + | + | 30 | 33–83 | <12 nM | 100 | TU1000mg/12 weeks | Parallel |
All data are reported as mean ± SD
BA Controlled cohort before-and-after comparisons, TE testosterone enanthate, TU testosterone undecanoate, TC testosterone cypionate, NR not reported. Adapted from ref. [85]