No age related effects on testosterone pharmacokinetics were observed in clinical trials of Androderm in men up to 65 years of age. In a group of 9 elderly testosterone deficient men (65-79 years of age, average baseline testosterone level 184±50 ng/dL), a single application of two Androderm 2.5 mg systems to the back resulted in an average testosterone level of 591±121 ng/dL with a T_max of 14.2±4.2 hours. The total testosterone delivered over the 24-hour application time was 3.8±0.6 mg, approximately 20% less than the average amount delivered in younger patients.

There is insufficient information available from Androderm trials to compare testosterone pharmacokinetics in different racial groups.

There is no experience with use of Androderm in patients with renal insufficiency.

There is no experience with use of Androderm in patients with hepatic insufficiency.

See "Precautions" below

CLINICAL STUDIES

In clinical studies using the Androderm 2.5 mg system, 93% of patients were treated with two systems daily, 6% used three systems daily, and 1% used one system daily.

The hormonal effects of Androderm (testosterone transdermal system) as a treatment for male hypogonadism were demonstrated in four open-label trials that included 94 hypogonadal men, ages 15 to 65 years. In these trials, Androderm produced average morning serum testosterone concentrations within the normal reference range in 92% of patients. The mean (SD) serum hormone concentrations and percentage of patients who achieved average concentrations within the normal ranges are shown in Table 3 below.

Table 3: Individual morning serum hormone concentrations (ng/dL) and percent of patients with mean concentrations within the normal range during continuous Androderm treatment (n=94).

A physiological suppression of the pituitary/gonadal axis occurs during continuous Androderm treatment leading to reduced serum LH concentrations. In clinical trails, 10 of 21 (48%) of men with primary (hypergonadotropic) hypogonadism achieved normal range LH concentrations within 6 to 12 months of treatment. LH concentrations may remain elevated in some patients despite serum testosterone concentrations within the normal range.

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