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Androderm

Clinical Pharmacology
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Clinical Pharmacology

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
Brand Name: Androderm
Generic Name: Testosterone Transdermal System
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