Wednesday Bubble: Will LibiGel liberate testosterone for women?

Posted by Liz on Oct 6, 2010 in Uncategorized | 1 comment

Female sexual disorder, also known as hypoactive sexual desire disorder (HSDD, i.e. lack of sexual desire) is big business and the race for the gold ring continues. While the FDA effectively put a halt to the antidepressant flibanseran only months ago, testosterone therapy continues to drive the march towards finding a cure for a low libido. The question remains, however, is this a good or bad strategy? And how about risks and benefits of adjunctive testosterone? Is it safe?

HSDD is a disorder that robs a woman of her libido and sexual desire. It is believed to affect up to 36% of women between the ages of 20 and 70, although slightly higher numbers of women with some degree of lowered sexual desire have been reported. Especially affected are women who have had their ovaries removed and have entered menopause as a result; these women in particular, have low testosterone levels. Notably, however, not all women who experience diminished sexual desire have low testosterone levels and the cause of HSDD is unknown. In addition to physical causes, relationship and interpersonal/psychological issues are also believed to play a role, making the condition even more difficult to treat.  And while testosterone may be helpful for boosting libido, it has also been linked to side effects that include acne, excessive hair loss or growth, hoarseness, weight gain, insomnia, voice deepening and migraines. More importantly, use of testosterone has also been shown to increase cholesterol levels in some women, thereby raising the risk for heart disease.

According to research, the HSDD market ranges from $2 to $5 billion. Even more troubling is the fact that in 2009 alone, physicians wrote more than 4 million prescriptions for testosterone to treat HSDD even though it’s not approved as a therapeutic strategy.

LibiGel® is a topical testosterone gel that is applied to the upper arm. Thus far, it has been shown in short-term, 3 month clinical trials, to significantly increase the number of  “sexually satisfying” events by as much as 238% without serious side effects. Since these early trials, the company has been studying over 2,000 postmenopausal women over the age of 50  with an elevated risk for heart disease to observe how well the gel does over the long-term (i.e. 3 years). Thus far, the manufacturer BioSante reports that the rates of reported cardiovascular events and breast cancer are very low and plans to present  interim data later this week at this year’s North American Menopause Society Meeting.

Is LibiGel going to liberate sexually dysfunctional women? And what about the other factors that affect desire, such as relationship status, self-esteem, stress and anxiety? Should we be concerned that physicians already prescribe testosterone ‘off-label’ for millions of women and that the company actually reports that over 90% of women using testosterone unapproved for this use would switch to LibiGel once it’s approved?

I am not quite sure if this is an example of irresponsible medicine or an untapped need. I would like to believe that LibiGel might be effective for certain women who have been forced into menopause due to physical conditions. On the other hand, doesn’t the medical treatment of HSDD ignore the obvious: that there are behavioral, social and environmental factors at play that testosterone therapy won’t and can’t address?

What do you think? Is this a bubble to be burst or the “re-desire” revolution? Only time will tell.