Twenty-nine patients, previously treated with testosterone, completed 12 months of Androderm treatment. Following an 8-week androgen withdrawal period, Androderm treatment produced positive effects on fatigue, mood and sexual function. The percent of patients complaining of fatigue decreased from 79% to 10% during treatment (P<0.001).

The average patient depression score (Beck Depression Inventory) decreased from 6.9 to 3.9 (p<0.001). Nocturnal penile tumescence and rigidity monitoring showed an increase in mean duration of erections 0.23 to 0.39 hours per night (p=0.01) and an increase in penile tip rigidity from 18% to 50% (p<0.001). The total number of self-reported erections reported increased from 2.3 to 7.8 per week (p<0.001)

Comparison with intramuscular testosterone: Sixty-six patients, previously treated with testosterone injections, received Androderm or intramuscular testosterone enanthate (200 mg every 2 weeks) treatment for 6 months. The percent of time that serum concentrations measured throughout the dosing interval remained within the normal range were as follows:

Sexual function was comparable between groups.

Effect on plasma lipids: In 67 men treated for 6 to 12 months, the average (SE) serum total cholesterol and HDL concentrations were 199 (7.6) ng/dL and 46 (2.3) ng/dL.

Compared to baseline values during a hypogonadal state achieved by 8 weeks of androgen withdrawal in 29 patients, the following changes in lipids were observed during 1 year of Androderm treatment: Cholesterol decreased 1.2%; HDL decreased 8%; Cholestero1/HDL ratio increased 9%. In these patients, lipids measured during Androderm treatment were not significantly different from those measured during prior IM injection treatment.

Effects on the prostate: Prostate size and serum prostate specific antigen (PSA) concentrations during treatment were comparable to values reported for eugonadal men. One case of prostate carcinoma occurred during Androderm treatment; two cases were detected during IM treatment.

REFERENCES

1. Mazer NA, et al. Mimicking the circadian pattern of testosterone and metabolite levels with an enhanced transdermal delivery system. In Gurney, Junjinger, Peppas, eds. Pulsatile Drug Delivery: Current Applications and Future Trends. Stuttgart: Wiss. Verl.-Ges.; 1993, 73-97.

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