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by Robert MacKay, Wednesday, July 25, 2012 | Categories: Female Sexual Dysfunction

The European Medicines Agency (EMA) has announced that the marketing authorisation (MA) for Intrinsa in the European Union has been withdrawn. This product has been available since 2006 and has been used for the treatment of hypoactive sexual desire disorder (HSDD) in women.

Warner Chilcott Ltd, the MA holders, voluntarily requested that the MA be removed and this wish was carried out subsequently by the European Commission. It seems that the product was not commercially viable.

The Online Clinic will no longer prescribe this treatment for HSDD but we will keep patients informed of future female sexual dysfunction therapies that we feel will benefit our female sexual dysfunction patients.

The human sex drive is often thought to be greater among men and this has always been put down to the higher levels of testosterone in the male body but a recent study carried out at the University of Michigan has prompted us to question the role of testosterone in sexual desire. The results of the study are published in the Archives of Sexual Behaviour and offer us further insight into the validity of an area of medicine that has been labelled female sexual dysfunction (FSD).

105 men participated in the study and 91 women and they answered questions regarding their sex lives, their attitudes towards sex, to their own bodies and with sexual desire. Their testosterone levels were also checked.

Having always thought that a high level of testosterone in men was the reason that men had greater sex drives than women, the researchers were surprised to discover that women who had higher levels of testosterone in their bodies were less inclined to want to have sex with a partner than women with lower levels of testosterone. Furthermore, women with higher levels of the sex hormone were more inclined to masturbate than women with lower levels of testosterone, even though they did not desire sex with a partner as much. Sexual desire seems far more layered an issue than previously thought. Maybe our definition of sexual dysfunction is not even correct?

Although the study size was very small, the outcome leads us to think that this whole area of female sexual dysfunction is wrong-headed. If a woman does not desire sex with another person and she is happy with that, is this sexual dysfunction? If she is unhappy with the situation then that is a completely different matter. If the findings of this study are borne out in a further, much larger study, it would lead us to the conclusion that scientific research focussing on testosterone levels is heading in the wrong direction. Remember that the biggest sexual organ in the body is the brain, not the testes or the ovaries. Our guess is that the scientific community is looking in the wrong area for a solution – if indeed there is a problem to begin with…

You may remember that we have written about Libigel - a potential new treatment for hypoactive sexual desire disorder in women. Previous phase III trials for Libigel, showed that the treatment increased the number of sexual events that were considered satisfying, increased feelings of sexual desire and also lessened any stress linked to low levels of desire. However, the results of the placebo in the double blind trial also gleaned positive results that were higher than expected and since there was not much of a disparity between the outcomes from both the drug and the placebo, Libigel did not fair too well in terms of efficacy.

This time around, the pharmaceutical company responsible for the drug, Biosante Pharmaceuticals, is addressing this issue in the hope that they will be able to demonstrate that Libigel’s effects will far outweigh the effects of the placebo. Simultaneously, the pharmaceutical company will continue with its phase III cardiovascular and breast cancer risk trials. This study is the largest of its kind assessing the safety of the use of testosterone in women.

The efficacy trial has not yet commenced as Biosante Pharmaceuticals is currently designing the study and they will also apply for Food and Drug Administration (FDA) for a Special Protocol Assessment (SPA) before they begin. The efficacy endpoints will be the same as in the previous trial.

There is clearly an unmet demand for pharmaceutical products in this area of medicine but we are not entirely sure how Libigel will be different from Intrinsa (other than the mode of application.)

by Robert MacKay, Tuesday, March 20, 2012 | Categories: Female Sexual Dysfunction | Womens Health

Once again the topic of the female orgasm has come up in the news and it confirms that there is still a lot we don’t know about the female body and how the orgasm occurs. There is some empirical evidence linking the orgasm to exercise. 40% of the women participating in a survey reported such an experience in places such as their gym, embarrassingly, or even their sitting room carpet where the orgasm was brought on by repetitions of tummy crunches and other such abdominal exercises. The correlation between orgasm and these exercises was particularly strong among the women who participated but others experienced orgasm while climbing rope, lifting weights or running even.

Interestingly, these events were not associated with sexual fantasy or sexual thoughts of any kind, allowing us now to look at exercise as a form of treatment for this branch of female sexual dysfunction. If nothing else, this discovery might give some of us the impetus to go to the gym more often!

Sometimes when women say, ‘not tonight, I have a headache’, they really mean it; 90% of women who are treated for headache and migraine report problems with sexual function. This dysfunction is commonly reported as pain when having sex and a lack of sexual desire, which is also known as hypoactive sexual desire disorder (HSDD), one aspect of the umbrella term for sexual problems and women, female sexual dysfunction (FSD). These kinds of headaches include migraines and chronic headaches, which are characterised as more than 15 headaches in the month.

Last week it was found that 91% of women being treated for headache or migraine and who were participating in an Italian survey, were also experience less than normal levels of sexual function, with 20% diagnosed with HSDD. 17% felt they had a low sex drive but they were unconcerned about it.

Previous research shows that all types of chronic pain will have an effect on sex drive and the ability to become aroused. The researchers behind the survey also say that often headaches accompany other disorders such as depression and these disorders could be the direct link to sexual dysfunction rather than the headaches themselves.

There are still few treatments available for FSD and since libigel’s late stage trials did not go so well, we are excited about such treatments in trial stage at the moment. Trimel Pharmaceuticals Corp. is happy with the results of mid-stage trials in which they met all of their primary goals with their drug, Tefina, a gel containing testosterone that is administered through a nasal device.

The drug is specifically for women who suffer from anorgasmia, which describes the condition where women cannot reach orgasm, and according to the pharmaceutical company, affects one in five women before and after menopause, all over the world.

At the moment, only Intrinsa is licensed for women with HSDD but it is appropriate for very few women who suffer from low libido because they must be menopausal or post-menopausal and also be on oestrogen replacement therapy.

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