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Androderm
Clinical Pharmacology
Androderm
Figure 2: Mean (SD) steady state serum testosterone concentrations during nightly application of Androderm 2.5 mg systems in 29 hypogonadal male patients, 27 patients used 2 systems nightly and 2 patients used 3 systems nightly. Area between the dashed lines shows the 95% confidence interval for the circadian variation observed in healthy young men.1 System application (t=0) at approximately 10 PM.
Table 1: Steady-state serum testosterone pharmacokinetic parameters in hypogonadal men measured during continuous Androderm (testosterone transdermal system) treatment.
| Parameter | Units | n | Mean | SD |
| Cmax | ng/dL | 56 | 753 | 276 |
| Cavg | ng/dL | 56 | 498 | 169 |
| Cmin | ng/dL | 56 | 246 | 120 |
| Tmax | hr | 56 | 7.9 | 2.2 |
| T1/2 | min | 29 | 71 | 32 |
| CL | L/day | 49 | 1304 | 464 |
Cmax = maximum serum concentration
Cavg = average serum concentration (AUC/24 hr)
Cmin = minimum serum concentration
Tmax = time of maximum serum concentration
T ½ = elimination half-life
CL = clearance
In a group of 34 hypogonadal men, application of two Androderm 2.5 mg systems to the abdomen, back, thighs, or upper arms resulted in average testosterone absorption of 4 to 5 mg over 24 hours. The serum testosterone concentration profiles during application were similar for these sites (Table 2). Applications to the chest and shins resulted in greater inter-individual variability and average 24 hour absorption of 3 to 4 mg.
Table 2: Mean serum testosterone concentrations (ng/dL) measured during single-dose applications of two Androderm 2.5 mg systems applied at night to different sites in 34 hypogonadal men
| Sample Time (hr) | Abdomen | Back | Upper Arm | |||||
| Mean | SD | Mean | SD | Mean | SD | Mean | SD | |
| 0 | 90 | 82 | 80 | 74 | 85 | 76 | 81 | 69 |
| 3 | 286 | 201 | 429 | 252 | 271 | 201 | 308 | 226 |
| 6 | 476 | 236 | 608 | 250 | 489 | 254 | 468 | 245 |
| 9 | 570 | 234 | 613 | 214 | 592 | 251 | 534 | 204 |
| 12 | 575 | 244 | 588 | 233 | 594 | 247 | 527 | 199 |
| 24 | 352 | 164 | 403 | 174 | 367 | 161 | 332 | 124 |
Generic Name: Testosterone Transdermal System
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