Endocrine Abstracts

Background

Transdermally absorbed alcohol-based testosterone gel has presented an alternative method of gonadal therapy. This study was designed to investigate the clinical effectiveness of this alternative hormonal replacement.

Method

97 men requiring testosterone replacement therapy for primary (21%) or secondary (79%) hypogonadism were recruited. The subjects underwent physical examination, psychological assessment by questionnaire and biochemical and haematological blood sampling at baseline, 3, 6 and 12 months of treatment.

Results

Pre-treatment serum testosterone was consistent with deficiency, with an average testosterone 6.34 nanomoles per litre (geometric mean; n=97), rising to 16.7 nanomoles per litre (n=69; range 1.6-32.9 nanomoles per litre) at 3 months and 24.1 nanomoles per litre (n=41; range 5.5-48.1 nanomoles per litre) at 6 months (reference interval 8.7-28.7 nanomoles per litre). Testosterone conversion to oestradiol resulted in an elevation from 62.1 picomoles per litre (n=95) at baseline to 110.5 picomoles per litre (n=71) at 3 months and 118.9 picomoles per litre (n=39) at 6 months therapy (reference interval 0-191 picomoles per litre). PSA showed an expected rise from a baseline of 0.86 micrograms per litre (n=94) to 0.99 micrograms per litre (n=71) at 3 months and 0.97 micrograms per litre (n=36) at 6 months (reference interval 0-4 micrograms per litre). Haemoglobin showed a marginal elevation from a baseline of 15.06 grams per decilitre (n=94) to 15.4 grams per decilitre at 3 months and 15.78 grams per decilitre (n=43) at 6 months (reference interval 13.5-17.5 grams per decilitre). Discontinuation occurred in only 5 subjects.

Conclusion

This study shows transdermal alcohol-based testosterone gel provides effective treatment of male hypogonadism, associated with high patient acceptability and a low incidence of complications. Clinical parameters studied showed no deleterious alteration and there was no significant evidence of complications from polycythaemia or prostatic enzyme elevation in the group overall.