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Should we prescribe testosterone patches for female sexual dysfunction? Latest evidence suggests we should not

March 8th, 2009

Dr Petra

Female Sexual Dysfunction is a controversial problem. While undoubtedly many women do have problems with their sex lives; the cause(s), prevalence and treatment(s) of women’s sexual problems are hotly debated.

In particular current arguments are ongoing among therapists, educators and clinicians on whether and when medical treatments should be offered for female sex problems – particularly the prescription of testosterone.

For the past few years testosterone patches have been available for women with sexual dysfunction in some countries, however new evidence suggests they may not be effective.

In this blog I’ll be covering the lowdown on female sex problems and the latest evidence on testosterone therapy, along with a rather depressing postscript that shows just how long people like me have been trying to get the media to think critically and ask questions about testosterone therapy as a treatment for female sexual dysfunction.

It’s another long one I’m afraid, but it is important so I hope you’ll forgive me.

So what are the main problems women have?

There are several areas where women can experience sexual problems, the most common ones being:
A lack of desire for sex
Problems in experiencing orgasm
Pain during/after sex
Penetration difficult/impossible

What causes those problems?

These sexual problems in women can be caused by numerous and often interacting factors including:
- Physical or mental health problems (such as diabetes, heart disease or depression, cancer)
- Gynaecological or urinary problems (including thrush, cystitis, sexually transmitted infections)
- Relationship problems (such as arguments, jealousy, or communication difficulties)
- Stress (from too much work or workplace problems, being overloaded with housework, a lack of partner support, or financial worries)
- Not knowing or being able to effectively explore or communicate what turns you on
- Lack of privacy for sex
- Concerns over pregnancy (worries about getting or not getting pregnant)
- Past or current physical, emotional or sexual abuse
- Body image or confidence issues
- Lack of sex education or holding negative beliefs about sex

What can be done to help women?

Where this becomes an issue is how these problems are understood and addressed. Many therapists, educators and healthcare workers believe that most of women’s problems can be attributed to the causes above and therefore the appropriate way to tackle them is through education, therapy or confidence building/consciousness raising. Where the cause is a physical or psychological health problem then appropriate healthcare should be provided.

However, there are others who see female sexual problems – particularly with desire and orgasm difficulties – as a clinical condition. They have coined the phrase Female Sexual Dysfunction as a descriptive for this (and latterly described lack of desire as ‘Hypoactive Sexual Desire Disorder or HSDD). Unsurprisingly the biggest supporter of this stance has been the pharmaceutical industry that has been accused of rebranding a common non-clinical problem into a medical condition.

Background to the Intrinsa patch

One treatment option recommended for women with HSDD has been the Intrinsa patch. In the US the Food and Drug Administration turned down P&G’s application to develop and sell the patch due to concerns over safety and efficacy. You can read a summary of this case here.

In the UK and the rest of Western Europe permission was given for the patch to be prescribed to women who had undergone surgical menopause (hysterectomy and oophrectomy) by the EMEA (European Medicines Agency). Although the EMEA insisted women on Intrinsa should also be on oestrogen therapy and Proctor and Gamble were tasked to use a ‘Risk Management Plan’ to monitor the safety of women using the patch.

This led to concerns from some that women in the US were either being protected from/denied treatment women in Europe were getting (depending on how you understood FSD).

Are transdermal testosterone patches safe and effective?

A recent review of Intrinsa just published in the journal Drug and Therapeutics Bulletin suggests that transdermal testosterone patches are not particularly helpful in overcoming women’s sexual problems.

The paper looked at published clinical research on Intrinsa (a transdermal testosterone patch) and noted the following problems:
- sample sizes were small and often highly selective groups of women who were not representative of the wider female population
- diagnosing sexual problems was done by using either non-validated questionnaires, or self report
- a ‘large placebo response’ was noted, attributed in part to participants signing up to the studies because they wanted to see an improvement in their sex lives
- some of the participants were not believed to have a sexual dysfunction (in clinical terms) and should not have been enrolled in the research
- the number of additional satisfying sexual encounters experienced by women using the Intrinsa patch compared to placebo was very small (in some studies only 1-3 more sexual encounters a month)
- adverse events from the patch (observed in placebo and study groups) were noted in 75% of cases (these were mostly irritation and itching caused by the patch, although other side effects noted included acne, hair loss or gain, breast pain, weight gain, insomnia, migraine and voice deepening)
- studies only tested the drug for a short period of time, so it is impossible to judge the health impacts of using such medication long term (in particular there are concerns about increased risks of cardiovascular disease and breast cancer through using testosterone supplements frequently)
- the majority of the studies were drug company funded, making it difficult to find independent evaluations of Intrinsa

The paper concludes
Hypoactive Sexual Desire Disorder (HSDD) is defined as a form of sexual dysfunction that causes absence of sexual desire, fantasies or thoughts and causes distress to the individual. However, the diagnosis is subjective, and the role that testosterone therapy might play in treatment of sexual dysfunction remains unclear. Intrinsa, a testosterone patch, has recently been licensed for women diagnosed with HSDD and who have undergone menopause due to bilateral oophorectomy and hysterectomy. The published evidence so far is based on highly selected women and only shows small improvements in sexual parameters and large placebo responses. Also, the long-term safety of the treatment is unknown. Unwanted effects are common and not always reversible. For all these reasons, we cannot recommend Intrinsa for the use in women with sexual dysfunction.

This is clearly a major problem for Proctor and Gamble as well as other drug companies developing testosterone products for female sexual dysfunction. How P&G and other pharmaceutical companies will respond remains to be seen. I predict they will fight as the female sexual dysfunction drug market represents a very lucrative area.

At this time, as well as companies trying to develop testosterone therapy, there are others such as Boehringer Ingelheim who are focusing on using an antidepressant drug (Flibanserin) to target HSDD (more on this in a future blog). Companies investing in the antidepressant drug instead of testosterone therapy will no doubt be delighted that this marketplace has been cleared, but that doesn’t mean their products are necessarily any more safe or effective – in fact the critical appraisal used within this latest research from the Drug and Therapeutics Bulletin could equally be applied to the antidepressant drug therapy approach (and my hunch is it would find similar outcomes).

Within the UK it seems NHS practitioners should not prescribe the patch, although again how that will happen in practice remains to be seen. Women with sexual problems may well benefit from sex/relationship therapy, but since there are a limited number of practitioners offering services on the NHS this could be a problem for women needing assistance. And, as you can see from the list above not all the problems women encounter can be fixed by therapy alone (any more than they can be fixed by a hormone patch).

If you are currently using Intrinsa, you will need to speak to your doctor or therapist about what to do next. Private doctors will, I suspect, continue to prescribe testosterone as a treatment for low sexual desire in women – even if the evidence base does not support this.

This story will come as good news (and no surprise) to those who have been campaigning against the medicalisation of female sexual problems – and this patch in particular. However, there remains one small problem of how it has taken this long to get this information into the scientific and public arena. After all, the studies appraised in this research have been available for a while – as have widespread criticism (see below). This should have been fully evaluated before the patch was ever given a licence in Europe. One has to wonder, given these findings, why the patch was ever approved in Europe to begin with.

Postscript

I’ve been following, and blogging about, the Intrinsa patch for the past five years. All that time I’ve been raising issues about the way the patch has been researched, reported, and understood. Below are a selection of my blogs dealing with this issue (going back to 2004). While it’s always nice to be proved right about something, it’s also depressing to see how long myself and others have been challenging this issue (particularly with the media) – with little effect until now.


Media Drug coverage of Intrinsa on the NHS


An account of what was going on with Intrinsa just before it was licensed for use in Europe

How the media misunderstand/misreport female sexual dysfunction and related drug treatments (in particular promoting Intrinsa before it had been passed for use in Europe)

In Spinning Sex Research I reported on how after being turned down for FDA approval, P&G published data from their Intrinsa trials and put out a press release entitled ‘Male hormones may help women after hysterectomy’ and in Did they bite? I followed up on the subsequent media coverage – noting (of course) how journalists didn’t spot the problems with the patch

And in one of my very first blog entries I report on how I tried to alert UK journalists to the problems with the Intrinsa patch in advance of the FDA hearings – and how I was told this ‘wasn’t newsworthy’

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