EFFECTS OF A NEW TESTOSTERONE TRANSDERMAL DELIVERY SYSTEM, BIOLIPID B2®-TESTOSTERONE IN HEALTHY MIDDLE AGED MEN: A CONFOCAL RAMAN SPECTROSCOPY STUDY

The Transdermal Delivery System (BIOLIPID B2®) is a nanoemulsion that can be applied directly to the skin by a metered pump to deliver hormones into the systemic circulation. The aims of this study were to assess the efficacy of BIOLIPID B2® to deliver testosterone systemically and evaluate the short-term effects on Thyroid-Stimulating Hormone (TSH), C-reactive protein (CRP) serum levels and blood pressure in middle aged men with testosterone deficiency. An open label randomized prospective study enrolled 14 Brazilian middle aged men with testosterone deficiency. The volunteers received in the forearm 50mg of transdermal BIOLIPID B2®-testosterone nanostructured formulation daily for 3 months. Confocal Raman Spectroscopy (CRS) was used to determine depth and concentration of testosterone on skin layers. Clinical parameters and serum concentrations were compared between the baseline and 3 months after treatment. Serum concentrations of testosterone, CPR and TSH changed significantly (p<0.05) after treatment. There was, also a significant change in the waist circumference, weight and body mass index (p>0.05) and no changes were observed in the blood pressure. No adverse events were attributed to this transdermal hormone replacement therapy protocol. The BIOLIPID B2® nanoemulsion formulation is safe and effective in reestablishing testosterone and Thyroid-Stimulating Hormone (TSH) serum levels. This transdermal protocol may serve as a strategy for hormone replacement therapy in middle aged men