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 a pplied directly to the skin by a metered pump to deliver hormones into the systemic circulation. The ai ms 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 tes tosterone 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 base line and 3 months after treatment. Serum concentrations of t estosterone, CPR and TSH changed significantly (p 0.05) and no changes were observed in the blood pressure . N o adverse events were attribu ted to this transdermal hormone replacement therapy protocol. The BIOLIPID B2 ® nanoemulsion formulation is safe and effective in reestabli shing testosterone and Thyroid - Stimulating Hormone (T SH) serum levels. This transdermal protocol may serve as a strate gy for hormone replacement therapy in middle aged men.