A study to be published in July’s edition of The Journal of Sexual Medicine has revealed that there has been a significant rise in the number of American doctors prescribing testosterone to combat hypoactive sexual desire disorder (HSDD) in women.
In a survey sponsored by BioSante, the pharmaceutical company seeking a treatment for female sexual dysfunction, it was revealed that of 2 million prescriptions written for testosterone, 21% of those were for women. 80% of doctors questioned said they believed there was a need for a treatment for HSDD. A further 90% said that they would rather prescribe an approved treatment rather than the off-label therapies currently available.
Testosterone is not yet currently approved as a treatment for HSDD in post-menopausal women in the US although Intrinsa is approved for use in the UK and Europe. BioSante is currently conducting the clinical trials required for FDA approval of an alternative therapy. At the moment there are three trials taking place, two Phase III trials involved 500 patients and lasting 6 months examining the efficacy of the treatment and one Phase III trial to check cardiovascular safety. The testosterone is delivered via a gel named Libigel, which BioSante hope to submit to the FDA for new drug approval in 2011.
In their paper, Dr Michael C Snabes and Stephen M Simes wrote that they believe many doctors are writing prescriptions for women suffering from low desire as an off-label indication. They warned that this practice was contrary to FDA prescribing standards and raised the risk that appropriate doses were not being delivered. They added that the statistics showed that there was a considerable number of women living with low sexual desire, many of whom felt their lives were being severely affected by the condition.