Androgen Replacement Therapy in Women

Marie Lebbe; David Hughes; Nicole Reisch; Wiebke Arlt


Expert Rev Endocrinol Metab. 2012;7(5):515-529. 

In This Article

Official Approval of Available Preparations

At present, no preparation for testosterone replacement therapy has been licensed by the US FDA; previous applications aiming at the indication of the treatment of HSDD have been rejected, mainly because of concerns with the lack of long-term safety and meaningful clinical responses. In 2006, the European Medicines Agency licensed the testosterone patches Intrinsa™ (Procter & Gamble, OH, USA), Livensa ™ (Warner Chilcott, Dublin, Ireland) and AndroFeme™ (Lawley Pharmaceuticals, Perth, Australia) for the treatment of HSDD in surgically menopausal women. Currently, there is no DHEA preparation available that has been produced according to good pharmaceutical practice standards, with significant variability in the quality of preparations available over the internet.