Experience with transdermal testosterone replacement therapy for hypogonadal men

BACKGROUND None of the existing options for longterm testosterone replaceme nt therapy (TRT) for hypogonadal men are ideal. Depot replacement at freque nt intervals and implants are effective but invasive and inconvenient for t he patient. Oral therapy results in poor hormone levels. Both are associate d with undesirable metabolic changes. A transdermal formulation therefore r epresents a potential therapeutic advance for testosterone replacement. OBJECTIVE To carry out a clinical audit of the acceptability and efficacy a s a treatment for hypogonadism of the first transdermal testosterone therap y available in the UK (Andropatch, SmithKline Beecham) compared with existi ng androgen replacement options. PATIENTS AND MEASUREMENTS Serum testostero ne and questionnaire data on treatment efficacy, side-effects, therapy pref erence, sexual dysfunction and partner's attitudes to therapy were obtained from 50 hypogonadal men prescribed long-term testosterone replacement. RESULTS Eighty per cent of the men returned analysable questionnaires. Eigh ty-four per cent experienced adverse effects with transdermal therapy, most commonly dermatological problems; 22% of the sample elected to continue wi th transdermal therapy, 72% returned to depot and 5% returned to oral thera py. The reservoir patches were judged to be too large, uncomfortable, visua lly obtrusive and noisy. Testosterone levels were comparable to those obtai ned with depot replacement with the added advantage of a more physiological pharmacokinetic profile. Men taking oral preparations were consistently un der-replaced. CONCLUSIONS Adverse events were substantially higher than reported from cli nical trials but in keeping with the spectrum of yellow card reports receiv ed by the Committee on Safety of Medicines. The pharmacokinetic advantages are thus largely outweighed by low patient acceptability. In its present fo rm transdermal therapy remains an expensive option for those who cannot tol erate depot testosterone replacement.