Endocrine Abstracts (2004) 7 P7

Transdermal testosterone replacement in men with evidence of borderline gonadal failure

Z Merza1, PM Mah1, A Blumsohn1, D Meads2, S Mckenna2, K Wylie3, R Eastell1 & RJM Ross1

1Division of Clinical Sciences (North), University of Sheffield, Sheffield, UK; 2Galen Research, ManchesterSciencePark, Manchester, UK; 3Department of Andrology (Urology), Royal Hallamshire Hospital, Sheffield, UK.

Background: Hypogonadism in men is associated with osteoporosis and low libido. Serum testosterone in men falls after the age of 40 years; however the benefits of replacement therapy are not established. We conducted a double-blind, placebo-controlled trial to investigate the effect of testosterone transdermal patches on bone turnover, body composition, quality of life (QoL) and well-being in men with borderline hypogonadism.

Methods: 38 borderline hypogonadal men (Testosterone < 10 nmol/l and/or free androgen index < 30; age 61.4 plus/minus 9.6 years) were randomised into the first treatment period of six months; 20 patients to testosterone (TestodermTTS body patch delivering 5 milligrams testosterone per day) and 18 patients to placebo. This was followed by a second 6-month open treatment period. The local ethics committee approved the study.

Results: Change in bone turnover during the first 6 months of treatment did not differ between the placebo and treated arms. Treatment significantly reduced urinary N-telopeptide cross-link of type I collagen (uNTX) on average by 17.2% over 12 months for the Testoderm group and reduced urine levels of immunoreactive free deoxypyridinoline (iFDpd) by 11.9% during the second treatment period for the placebo group. There was a 5.2% reduction in total fat mass during testosterone treatment vs placebo; and during the second period of treatment Testoderm increased total hip bone mineral density by 0.8% and lean body mass by 1.6% in the placebo group. For QoL, the mean scores of the placebo group declined at first, then improved after treatment was introduced at 6 months while mean scores for the Testoderm group remained stable over the first 6 months and improved between 6 and 12 months. Conclusion: Transdermal testosterone patches reduce bone resorption and total fat mass in borderline hypogonadal men and treatment is associated with improved QoL and sense of well-being.

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