Table 1.
Summary of special interest adverse events related to sexual function
| DB period | OL period | Combined periods | ||||
|---|---|---|---|---|---|---|
| Placebo n = 59 | Dutasteride n = 58 | Placebo DB‐dutasteride OL n = 49 | Dutasteride‐DB/OL n = 48 | Total n = 97 | Dutasteride combined n = 48 | |
| Impotence (erectile dysfunction) | ||||||
| Participants, n (%) | 3 (5) | 7 (12) | 1 (2) | 1 (2)† | 2 (2) | 8 (17)† |
| Maximum intensity | ||||||
| Mild | 2 (67) | 6 (86) | 1 (100) | 1 (100) | 2 (100) | 7 (88) |
| Moderate | 1 (33) | 1 (14) | 0 | 0 | 0 | 1 (13) |
| Onset | ||||||
| 0–3 months | 3 (100) | 7 (100) | 1 (100) | 1 (100) | 2 (100) | 7 (88) |
| >3 months | 0 | 0 | 0 | 0 | 0 | 1 (13)‡ |
| Duration, median (range) | 28 days (24–153) | 30 days (12–228) | 181 days | 176 days | 178.5 days (176–181) | 67 days (12–228) |
| Period of resolution | DB = 3 | DB = 5, OL = 2 | TFU | OL | OL = 1, TFU = 1 | DB = 5, OL = 2, TFU = 1 |
| Decreased libido | ||||||
| Participants, n (%) | 2 (3) | 1 (2) | 2 (4) | 1 (2) | 3 (3) | 1 (2) |
| Maximum intensity | ||||||
| Mild | 2 (100) | 1 (100) | 2 (100) | 0 | 2 (67) | 0 |
| Moderate | 0 | 0 | 0 | 1 (100) | 1 (33) | 1 (100) |
| Onset | ||||||
| 0–3 months | 1 (50) | 0 | 2 (100) | 1 (100) | 3 (100) | 0 |
| >3 months | 1 (50) | 1 (100) | 0 | 0 | 0 | >9 months |
| Duration, median (range) | 88.5 days (15–162) | 44 days | 77.5 days (27–128) | 135 days | 128 days (27–135) | 135 days |
| Period of resolution | DB = 2 | TFU | OL = 1, TFU = 1 | TFU | OL = 1, TFU = 2 | TFU |
| Ejaculation disorder | ||||||
| Participants, n (%) | 0 | 1 (2) | 0 | 0 | 0 | 1 (2) |
| Maximum intensity | ||||||
| Mild | 0 | 1 (100) | 0 | 0 | 0 | 1 (100) |
| Onset | ||||||
| 0–3 months | 0 | 1 (100) | 0 | 0 | 0 | 1 (100) |
| Duration, median (range) | 0 | 63 days | 0 | 0 | 0 | 63 days |
| Period of resolution | 0 | DB | 0 | 0 | 0 | DB |
Represents first occurrence of the specified adverse event (AE) in each period of the study (for participants with more than one event). †Includes organic erectile dysfunction. ‡Participant completed 3 months of double‐blind (DB) dutasteride treatment, and then experienced impotence during the first 3 months of open‐label (OL) treatment. AE, adverse event; TFU, targeted follow‐up (period).