Acrux libido drug readies for PII trials
Wednesday, 07 May, 2003
Acrux subsidiary FemPharm is poised to commence a Phase II clinical trial testing its proprietary Metered Dose Transdermal System for the delivery of testosterone to women with low libido.
According to Dr Andrew Humberstone, the director of pharmaceutical R&D at FemPharm, low testosterone levels in women have been linked with experiencing low libido, as well as fatigue and a reduced sense of well-being.
"Several studies have shown that these symptoms can be improved by the administration of testosterone. However, there are currently no products approved for these indications and the establishment of the minimum effective and safe dose has been limited by lack of availability of low dose testosterone formulations suitable for women. Our aim is to develop a safe and effective treatment of low libido in these women," Humberstone said.
Using a study protocol designed with consultation with the US FDA, three doses will be tested against a placebo in 200 pre-menopausal women with low testosterone levels, in order to determine the minimum effective dose required to successfully treat libido problems.
Unlike other studies testing treatments for low libido, which generally rely on questionnaires to assess the impact of the treatment, FemPharm's trial has a quantitative endpoint specifically required by the FDA, measuring the increase in the number of "satisfactory sexual events" recorded by the patient during the four-month trial period.
"These are difficult studies to do -- the key is to carefully select participants with low testosterone and low libido and exclude women who have other factors that could affect libido such as depression or relationship problems," said Humberstone.
Results from the trial are expected to be available in about 12 months, he said. Another FemPharm product in development, an estradiol spray for hormone therapy, is expected to enter Phase III trials this year.
"This is a big move for us, going into an efficacy study for the testosterone spray," said Humberstone.
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