An open-label, phase 2, single centre, randomised, crossover pharmacokinetic study assessing two application areas of 0.5ml (5mg) of a testosterone 1% cream, ANDROFEME(Registered trademark) in healthy postmenopausal women

ANDROFEME (Registered trademark) cream is currently the only available testosterone product in Australia with widespread use in clinical practice. The available pharmacokinetics indicate the most appropriate dose for women is 0.5ml (5mg)/day. However the absorption of transdermal preparations is known to vary according to the area of application. This was not controlled for in prior studies. Furthermore, the investigators believe the upper arm is not an appropriate site for the drug application as 1) there is a greater risk of transfer of the applied drug to others; 2) contamination when blood is drawn for measuring testosterone levels is common (resulting in falsely elevated levels) and 3) the possibility of increased blood levels of testosterone in the ipsilateral breast. In this study we will evaluate the pharmacokinetics of two application sites of 0.5ml (5mg) of this testosterone 1% cream in postmenopausal women: an area on the upper outer thigh/ lower buttock approximately the size of the palm (approximately 80cm2) and a broad area on the outer thigh/ lower buttock (approximately 300cm2).