An open-label, phase 2, single centre, randomised, crossover study of two doses of Androfeme in healthy postmenopausal women

In healthy reproductive-aged women, circulating testosterone is produced by the ovaries and adrenal glands. The main cause of lowered testosterone levels in women is the natural decline with age, hypopituitarism, adrenal insufficiency, premature ovarian failure, bilateral oophorectomy, oral glucocorticosteroid therapy, and oral oestrogen therapy. Biological data support important physiological effects of testosterone in women. Studies have shown testosterone therapy in women who have low testosterone levels and a reduced libido improves sexual desire and general well-being. Testosterone replacement therapy has been used for many years utilising different routes such as injection, cream, gel and implant. Transdermal administration of testosterone has the advantages of avoiding the potential hepatic toxicity of oral androgens, is easily discontinued, and allows more physiological control of testosterone levels than subcutaneous implants. However, transdermal administration of testosterone in the form of a cream has the potential advantages of greater flexibility of dose adjustment and the absence of discomfort and irritation which may occur with other transdermal therapy such as a patch. Androfeme cream is currently the only available testosterone product in Australia with widespread use in clinical practice. No study has investigated the pharmacokinetics of the current dispensing method for Androfeme. Androfeme is supplied with a dose applicator calibrated in 0.5ml graduations. Each 0.5ml delivers a 5mg dose of testosterone. The patient should be directed to measure the appropriate dose using the graduated applicator and then apply to the skin. Presently patients are asked to commence with a 0.5ml dose (5mg) but we have no idea whether this dose is sufficient or whether a 1.0ml dose (10mg) is needed to achieve the desired blood levels for a therapeutic effect. This study will, for the first time, compare the pharmacokinetics of two doses of Androfeme in postmenopausal women: 0.5ml (5mg) and 1.0ml (10mg).