Female sexual dysfunction is getting the attention that it deserves with the release of the new FDA Guidelines
Female sexual dysfunction (FSD) is a complicated issue because it’s caused by a combination of physical, psychological, and social issues — from stress to guilt about sex to hormonal imbalance. It’s very hard to say that dysfunction is caused only by one of these factors.
Since about 2005 there has been a growing perception of gender bias towards the way the FDA view and approved treatments for sexual dysfunction in men compared to women. Thirty-five FDA-approved options for men compared to three (all vaginal estrogen creams) for women saw a time of great debate on the issue in 2013 and 2014 in the USA.
The need for a concise and clear statement prompted the FDA late last year (2016) to develop and release the Guidelines for Industry on developing drugs for treatment of low sexual interest, desire and/or arousal in women.
This document states ” Sexual dysfunction can adversely affect various aspects of life for a woman, including her relationship with her partner. There is a medical need for development of drugs with favourable benefit-risk profile to treat women with sexual dysfunction.”
This is a watershed publication with the world’s most stringent regulator acknowledging female sexual dysfunction is real and appropriate treatments are required.
With one in 10 women in the US lacking sexual desire to an extent that it impacts their quality of life, there is no doubt there is a need for an effective treatment. The FDA approved the drug flibanserin (Addyi®) in August 2015, the first oral prescription drug for the treatment of hypoactive sexual desire disorder in pre-menopausal women. While Viagra directly increases blood flow to the penis to cause an erection, flibanserin looks to alter the neurotransmitters within the brain involved in sexual excitation. Overall there was about a 10% increase in meaningful improvements in SSE’s (0.4 satisfying events per month more than placebo). This is in contrast to Viagra which is somewhere between 30% to 80% effective. There are negatives to using flibanserin including restrictions on prescribing and access only from approved pharmacies, boxed warnings imposed by the FDA due to the increased risk of severely low blood pressure and fainting as well as a complete abstinence from consuming alcohol plus the $750 per month cost of treatment. Nevertheless this was a positive step in the right direction and the draft Guidelines is another positive.
Female arousal is complicated involving neurotransmitters, sex hormones (including testosterone) and other factors. Many women are surprised to learn than their bodies produce testosterone just like men, just not in the same quantity (about 5-10% of male production). Testosterone is produced by the ovaries and adrenal glands of women with peak production occurring around 20 years of age, there is then a steady decline until at aged 40 women will produce about half as much with the decline continuing on after this point. Testosterone is as important for women as oestrogen and progesterone are, it is essential for a woman’s physical and mental well being.
Receptors for testosterone are located all through the body including the heart, bones and brain. In 2002 many of the world’s leaders in gynaecology and women’s health came together to discuss testosterone deficiency in women. They concluded that as well as a decrease in libido and sexual responsiveness, testosterone deficient women may also experience the following symptoms,
- diminished sense of well-being, dysphoric mood, anxiety, irritability and/or blunted motivation
- persistent, unexplained fatigue
- potential bone loss, decreased muscle strength and/or changes in cognition and memory.
So while testosterone can improve a women’s sex drive many also see improvements in overall general mental and physical well being.
Australia is the only country in the world where there is a pharmaceutical grade, commercially available testosterone products available for women. AndroFeme® has been formulated specifically for women as a 1% testosterone cream and is manufactured in an Australian government approved facility and is clinically trialled, stability and quality tested to international regulatory standards.
If you would like to find out more information about Testosterone For Women click on the booklet below.
For the complete FDA guidelines on Treatments for low sexual interest, desire and/or arousal, click on the link below.