Table 1.
Patients demographics and baseline clinical characteristics
| Characteristic | Placebo (n = 31) | Tadalafil (n = 101) |
|---|---|---|
| Mean age, years (range) | 51.7 (27.8–66.1) | 48.7 (26.6–67.7) |
| Mean weight ± SD (kg) | 83.97 ± 14.91 | 80.73 ± 11.68 |
| Mean height ± SD (cm) | 170.84 ± 5.53 | 172.79 ± 7.79 |
| Aetiology, n (%) | ||
| Psychogenic | 2 (6.5) | 11 (10.9) |
| Organic | 9 (29.0) | 31 (30.7) |
| Mixed | 20 (64.5) | 59 (58.4) |
| Erectile dysfunction severity measured by IIEF EF score, n (%) | ||
| Mild (17–30) | 11 (35.5) | 35 (34.7) |
| Moderate (11–16) | 12 (38.7) | 38 (37.6) |
| Severe (1–10) | 8 (25.8) | 28 (27.7) |
| ED duration, n (%) | ||
| ≥3 to < 6 months | 4 (12.9) | 15 (14.9) |
| ≥6 months to 1 year | 7 (22.6) | 10 (9.9) |
| ≥1 year | 20 (64.5) | 76 (75.2) |
| Smokers | 10 (32.3) | 36 (35.6) |
| Consumes alcohol | 2 (6.5) | 7 (6.9) |
| Mean weekly consumed alcohol units* | 0.13 | 0.12 |
| Pre-existing conditions, n (%)† | ||
| Patients with ≥1 condition | 18 (58.1) | 41 (40.6) |
| Diabetes mellitus | 8 (25.8) | 21 (20.8) |
| Hypertension | 7 (22.6) | 10 (9.9) |
| Benign prostatic hyperplasia | 2 (6.5) | 4 (4.0) |
| Hypercholesterolaemia | 1 (3.2) | 3 (3.0) |
| Hyperlipidaemia | 2 (6.5) | 1 (1.0) |
| Urinary tract infection | 2 (6.5) | 1 (1.0) |
Patients were included based on a history of erectile dysfunction. Subsequent assessment of erectile function by IIEF at baseline revealed that two (2%) tadalafil-treated patients had an EF domain score in the normal range (26–30).
*
Mean alcohol unit for randomised patients.
†
Conditions that are more frequent than 5% in any of the treatment group are shown in this table.