Table 5.
Percentage of Patients Predicted to Achieve Prespecified Exposure Ranges for the Testosterone Undecanoate 8‐Week and 10‐Week Regimens (Injection/Dose 10)
| Patients, % (95%PI) | |||
|---|---|---|---|
| Parameter | Concentration Range, ng/dL | 10‐Week Dosing | 8‐Week Dosing |
| Cavg | 300‐1000 | 97.4 (94.0‐100) | 98.3 (94.9‐100) |
| <300 | 1.7 (0.0‐5.1) | 0.9 (0.0‐2.6) | |
| >1000 | 0.0 (0.0‐1.7) | 0.9 (0.0‐3.4) | |
| Cmax | 1300‐1500 | 8.5 (4.3‐12.8) | 9.4 (5.1‐14.5) |
| 1800‐2500 | 3.0 (0.9‐6.8) | 3.4 (0.9‐6.8) | |
| <1500 | 90.6 (86.3‐94.9) | 88.9 (84.6‐94.0) | |
| <1300 | 82.1 (76.1‐88.0) | 79.5 (74.4‐85.5) | |
| >2500 | 0.0 (0.0‐1.7) | 0.0 (0.0‐1.7) | |
| Ctrough | >300 | 66.7 (59.0‐75.2) | 76.1 (67.5‐83.8) |
Cavg, average testosterone concentration during a dosing interval; Cmax, maximum observed testosterone concentration during a dosing interval; Ctrough, last observed testosterone concentration during a dosing interval prior to a subsequent dose; PI, prediction interval.