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A Dose-Response Study of Testosterone on Sexual Dysfunction and Features of the Metabolic Syndrome Using Testosterone Gel and Parenteral Testosterone Undecanoate

FARID SAAD^*,

LOUIS J. GOOREN

AHMAD HAIDER

AKSAM YASSIN^,||

^* Department of Men's Healthcare, Bayer-Schering, Berlin, Germany; the Gulf Medical College School of Medicine, Ajman, United Arab Emirates; VU University Medical Center, Amsterdam, The Netherlands; Urology Office, Bremerhaven, Germany; and the ^|| Department of Urology, Segeberger Kliniken, Norderstedt, Germany

Correspondence to: Dr Farid Saad, Bayer-Schering, Department of Men's Healthcare, 13342 Berlin, Germany (e-mail: farid.saad{at}bayerhealthcare.com).

The objective of this study was to observe the dose-response effects of testosterone (T) treatment on symptoms of sexual dysfunction and the metabolic syndrome. Two cohorts of elderly men with late-onset hypogonadism were followed over 9 months. Group 1, consisting of 28 men (mean age, 61 years; mean T level, 2.07 ± 0.50 ng/mL), received long-acting T undecanoate (TU; 1000 mg); group 2, composed of 27 men (mean age, 60 years; mean T level, 2.24 ± 0.41 ng/mL), received T gel (50 mg/day) for 9 months. In patients treated with T gel, plasma T levels rose from 2.24 ± 0.41 to 2.95 ± 0.52 (statistically significant) at 3 months, 3.49 ± 0.89 (statistically significant) at 6 months, and 3.80 ± 0.73 ng/mL at 9 months (T level at 6 months was compared with T level at 3 months). With TU, plasma T levels rose from 2.08 ± 0.56 to 4.81 ± 0.83 (statistically significant) at 3 months, 5.29 ± 0.91 at 6 months, and 5.40 ± 0.77 ng/mL at 9 months. With TU, the plasma T levels were statistically significantly higher than with T gel With TU, there was a greater improvement in sexual symptoms and in symptoms of the metabolic syndrome. With both treatments, changes in waist circumference correlated with changes in total, low-density, and high-density lipoprotein cholesterol. Parameters of safety were not different between the 2 treatments. T administration had a beneficial effect on sexual dysfunction and symptoms of the metabolic syndrome in elderly men. The higher plasma levels of T generated with TU than with T gel were clearly more effective, indicating that there is a T dose-effect relationship.

     Key words: International index of erectile function, waist circumference, lipids, sex hormone–binding globulin, prostate safety, hematocrit.

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