Currently, there is not a huge amount of options available for women suffering from low sex drive. Indeed, it has been fairly hard to get female sexual dysfunction (FSD) acknowledged as a medical issue, rather than one rooted solely in the mind. It is therefore always heartening to hear that new treatments are in the pipeline, and so we at The Online Clinic will be watching medical firm BioSante’s clinical trials of their two new treatments with interest.
The first is an interesting variation on birth control, named ‘Pill-Plus’. The pill acts as a triple-hormone contraceptive, which means that as well as containing the hormones estrogen and progestogen, it also contains the hormone andogen. Decreased andogen levels lead to a waning in sexual desire, sexual activity and cause mood swings. It is thought that ironically enough, women on normal oral contraceptives can experience reduced sex drive due to the other two hormones. BioSante put out a press statement in September stating that their clinical trials had shown testosterone levels (testosterone being the hormone blamed for lowered female desire) revert to healthy levels in test subjects taking the pill. Clinical trials will be continuing in 2009.
The second drug being tested by BioSante is LibiGel, a gel-based formulation of testosterone that is applied to the arm and quickly absorbed into the system. The phase-two trial showed that the drug significantly improved sexual experience for surgically-induced post-menopausal women. A second trial is focusing on the effect of the drug in women experiencing a naturally-induced menopause (the majority of FSD sufferers are thought to be post-menopausal women). The trial had positive results and the company is now embarking on phase three of their clinical trials, intended to meet the safety regulations of the FDA (the U.S Food and Drug Administration).
The agreement reached between BioSante and the FDA, setting the parameters for eventual FDA approval, could have far reaching consequences for the future treatment of FSD, for it indicates that the FDA acknowledges that female sexual dysfunction is a treatable medical condition. Currently, no medication is approved by the FDA for the alleviation of FSD, though Instrina, Proctor and Gamble’s testosterone patch, was granted a license by the European Medicines Agency in 2007 and is prescribed by The Online Clinic where appropriate. In a press conference, Stephen M Sines, CEO of BioSante said, "This action by the FDA confirms the FDA's position that FSD and Hypoactive Sexual Desire Disorder are true diagnosable conditions ... with measurable endpoints that can be evaluated and which deserve therapeutic options”.
Though LibiGel is unlikely to be on the market until 2011 and Pill-Plus is still in the early testing stages, the prospect of new FSD treatments will be greeted enthusiastically. The only current option, Intrinsa, is suitable for just a limited number of patients. It is particularly encouraging that the drugs would appeal to two very different markets, pre and post-menopausal women, indicating that sufferers of all ages may eventually have access to suitable treatment.