SAFETY OF LONG-TERM TESTOSTERONE TREATMENT IN RELATION TO RESULTING ENDOCRINE PROFILES

M. Carruthers 1, M.R. Feneley 2

1 Mens Health Centre, London, UK
2 Institute of Urology, London, UK

Introduction: Because of the known differences in the endocrine profiles produced by the wide range of testosterone treatments currently available, it is difficult to make overall statements about their long-term safety. Though the short-term studies have been uniformly encouraging, they have generally been only between 1-3 years in duration. Extended trials are difficult and expensive to perform, and are only in the planning stages. While the outcome of such trials is awaited, it appears important to assess what safety data is available from current clinical practice.

Methods: An updated audit of the data from the UK Androgen Study (UKAS) of 1,675 men on testosterone treatment for up to 15 years will be presented. This includes studies on men treated with pellet implants, oral testosterone undecanoate (Restandol), mesterolone (Pro-Viron), transdermal testosterone (Testogel and Andromen Cream), and intramuscular testosterone undecanoate (Nebido). All patients were monitored on average every 6 months, with full endocrine, biochemical, haematological and urinary profiles taken fasting in the morning, together with measurement of blood pressure, and body mass index. The level of symptomatic improvement was checked by means of a standardized questionnaire, which together with the endocrine measurements was used to regulate the treatment dosage.

Results: Each of the six forms of testosterone used in the treatment of androgen deficient men in this on-going study has a unique and markedly different endocrine profile. The patterns of endocrine response seen in this audit of clinical observations will be compared with those reported in the published literature. Apart from the tendency for increased haemopoesis, seen more with high dose parenteral preparations, and easily corrected in the few cases where it is excessive, there were no adverse effects seen on the prostate, urinary function, liver function, and carbohydrate and lipid metabolism. The theoretical and practical advantages of preparations giving more physiological diurnal variation, versus those resulting in a 'steady state', are discussed. Conclusions: These findings support the view that carefully applied and properly monitored long-term treatment with testosterone has proved to be safe during the nearly 70 years it has been available.