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

Abstract

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 TSH (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 50 mg of transdermal BIOLIPID B2-testosterone nanostructured formulation daily for 3 mo. Confocal Raman Spectroscopy (CRS) was used to det. depth and concn. of testosterone on skin layers. Clin. parameters and serum concns. were compared between the baseline and 3 mo after treatment. Serum concns. of testosterone, CPR and TSH changed significantly (p<0.05) after treatment. There was, also a significant change in the waist circumference, wt. and body mass index (p>0.05) and no changes were obsd. 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 TSH (TSH) serum levels. This transdermal protocol may serve as a strategy for hormone replacement therapy in middle aged men. [on SciFinder(R)]