EFFECTS OF NANOSTRUCTURED TRANSDERMAL TESTOSTERONE DELIVERY SYSTEM IN HEALTHY MIDLE AGED MEN : A CONFOCAL RAMAN SPECTROSCOPY STUDY

The Transdermal Delivery System (BIOLIPID B2®) is a nanoemulsion that can be a pplied 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 sh ort - 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 testoster one 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 laye rs. 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) and no changes were observed in the blood pressure . N o adverse events were attributed to this transdermal hormone replacement therapy protocol. The BIOLIPID B2 ® nanoemulsion formulation is safe and e ffective in reestabli shing testosterone and