This Phase I dose-finding study provided clear evidence of the effectiveness of Ardana’s cream in the transdermal delivery of testosterone in females. The double-blind, randomised, placebo-controlled study involved 9 surgically menopausal women between 18 and 55 years of age. These subjects received in random order a single application of Testosterone Cream at a dose of 0.2g, 0.4g and 0.6g, or a placebo cream. Both placebo and active cream were applied to one upper arm only. Preliminary analysis of the data show that the three doses, 0.2g, 0.4g, 0.6g, resulted in an increase in the average concentrations of testosterone over 24 hours of 10.6, 16.2 and 20ng/dL respectively. The maximal concentrations were 36.6, 47.2 and 48.9 ng/dL respectively.
Ardana’s Testosterone Cream, which is also in Phase III clinical development for hypogonadal men in the US, is a novel, patented method of delivering testosterone. Because of its reduced surface area requirement, Ardana’s Testosterone Cream appears to deliver testosterone more efficiently than existing gel-based testosterone products. The cosmetic-like cream consistency and low alcohol content contribute to a potentially user-friendly preparation. Among other potential uses, Testosterone Cream could be developed as an androgen supplementation in the management of female sexual dysfunction and specifically hypoactive sexual desire disorder.
Huw Jones, CEO of Ardana, said: “Testosterone is naturally present in women and restoration of testosterone deficiency has the potential to treat associated conditions such as hypoactive sexual desire disorder.”