Phase II study to treat FSD

Cellegy Pharmaceuticals has announced positive results of a second interim analysis of a Phase II study using its product, Tostrelle (testosterone gel) 0.5%, to treat postmenopausal women with low testosterone levels who were distressed by symptoms of sexual dysfunction.

The study showed that Tostrelle was safe, produced testosterone levels that were within the normal range of young women (p<0.001) and produced a 65% improvement in the number of satisfying sexual events, a 30% increase over placebo. These results are similar to those demonstrated by other transdermal testosterone products to be clinically effective.

K. Michael Forrest, president & ceo, said: 'We are very pleased by these positive results. Based on these interim data and the feedback received at a recent meeting with the FDA, we have decided to stop enrollment in the Phase II study and have begun preparations for Phase III clinical trials.

'Tostrelle gel is a convenient, non-staining and non-irritating gel that can be applied on either thigh to an area about the size of the palm of a hand. Market preferences clearly favour elegant gel-based products over other types of dosage forms such as patches. In addition, the dose of the gel can easily be adjusted up or down using our metered dose system while patches deliver the same fixed amount of drug for all patients, making the gel form of therapy much more flexible. We believe there will be a large demand for this product, if approved.'

Dr Andre Guay, of the Lahey Clinic, Peabody, Massachusetts, an expert in the area of female sexual dysfunction and an investigator in the study, stated: 'Sexual dysfunction in women was brought to the forefront when it was reported in 1999 that 43% of women from age 18 to 59 had some form of sexual dysfunction. Nobody thought the problem was this prevalent, but others have verified these numbers in subsequent studies.

'More interesting in the literature is the fact that decreased libido was the most common symptom and it occurred in 30-32% of each decade of life, even in younger women. There are many causes, but a certain percentage of these women will be found to have low androgens. Our group recently reported decreased androgens in a group of young women complaining of sexual dysfunction who were perfectly healthy and not taking any medications. Accurate numbers are not yet available, but there may be over 10-15m women in the US who have low androgens.'