Efficacy and Safety of Androderm(TM) in Partially Androgen-deficient Aging Men with Erectile Dysfunction

Seo, Kyung Keun; Yoon, Seung Hwan; Kim, Sae Chul

Abstract

PURPOSES: To evaluate the effect of Androderm(TM) on sexual function and its safety in partially androgen-deficient aging men with erectile dysfunction.
MATERIALS AND METHODS
Two Androderm patches, designed to deliver 5mg of testosterone per day, were applied daily for 4 months to the back, abdomen, upper arm, or thigh of 21 patients (mean age 52.4+/-6.76 years; range 41-63 years) with partial androgen deficiency and erectile dysfunction, The degree of symptom using the Watts (sexual arousal, desire, orgasm, and satisfaction) and Davidson (number and quality of penile erections) questionnaires, Blood levels of total and bioavailable testosterone, estradiol, luteinizing hormone, follicle-stimulating hormone, and sex hormone-binding globulin were measured monthly. The safety variables examined were lipid profiles, liver and kidney function tests, prostate specific antigen, hematologic values, body mass index, and local skin reaction.
RESULTS
Blood concentrations of total and bioavailable testosterone and estradiol were significantly (p<0.05) increased, but all were within the normal range during androgen replacement with Androderm. One third of the patients reported improvement in the quality of their erections. there were no significant differences in Watts sexual function scores, number of spontaneous and morning erections, or the quality of erections compared with baseline data. No changes in blood lipid profiles, measures of liver and kidney function, PSA, hematologic values, or body mass index were noted. However, 22% of the patients dropped out of the trial because of severe skin irritation symptoms.
CONCLUSION
Androderm was partially effective in improving the quality of erection in partially androgen-deficient aging men and is physiologic and safe.