Hello and welcome to BJJP interviews and welcome to our new season of the podcast.

Hope you all had a great break over Easter and thanks again for listening to this podcast today.

My name is Nada Khan and I'm one of the associate editors of the BJTP.

In today's episode, we're speaking to Dr.

Stephen Gibbons, consultant clinical biochemist at Leeds Teaching Hospital NHS Trust, and Dr.

Claire Spencer, a GP partner and menopause specialist at the Meanwood Group Practice in Leeds.

We're here to talk about the recent clinical practice paper published here in the bjgp.

The paper is titled Optimizing Testosterone Therapy in Patients with Hypoactive Sexual Desire Disorder.

So thanks, Stephen and Claire, for joining me here today.

It's great to talk to you about this paper, especially because it's in an area of a lot of interest to patients and clinicians in general practice wondering what to do about testosterone prescribing.

I guess I wanted to kick things off, Stephen, really, by asking, what made you start investigating testosterone replacement in patients with hypoactive sexual desire disorder?

So it was actually a conversation with a colleague at work over coffee and she mentioned to me that she'd noted quite a lot of high testosterone in females of a particular age and she was asking why that might be.

So I explained it's probably because of TRT in this condition called hsdd, but that was kind of quite anecdotal at that point.

So we thought we'd do a clinical audit.

So myself and two colleagues, Kia and eloise, we audited 100 patients from Leeds.

So we looked at a sample of 100 patients on TRT for HSDD and we audited them against the British Menopause Society guidance, which state that you should do a pre testosterone measurement and then you should check at at six to eight weeks, I believe.

And what we found is that actually there was quite poor compliance with the BMS guidance.

And at this point we felt a little bit out of our depth.

But we thought, well, this is quite alarming.

Probably the most alarming thing was the number of patients with a really high testosterone that weren't adequately followed up.

So we thought, right, let's bring some clinical experts in at this point.

So that's when we got in touch with Dr.

Spencer and Dr.

Jasim and Dr.

Wal Ford, who's also on the paper.

She's a consultant endocrinologist at Leeds, and we kind of had a look at the data and we all agreed that, you know, there were significant findings.

And the question was why?

Because there are quite comprehensive guidance out there from the bms, but I think we all felt that potentially they lacked some of the finer detail.

Potentially in some areas they were a little vague.

So that's when we came up with these additional recommendations.

And they're certainly not supposed to replace the BMS guidance, but it's a supplementary kind of recommendations to support the BMS guidance.

So that's where we started, really.

And I guess if we just dial this back a bit.

Can you or Claire talk us through what is hypoactive sexual desire disorder and how common is it?

So hsdd, essentially, it's a condition where they get persistent absence of sexual dis.

Desires or fantasies.

So you might.

Some people might term it low libido, I suppose, but the difference between low libido and HSDD is that in HSDD there's an emotional component, so emotional distress.

And it doesn't just affect women, of course.

This affects both males and females.

But the prevalence seems to be much higher in females between.

Between about 15 and 20% of females will experience HSDD.

In males, it's probably slightly lower, around 5%.

And I mean, Claire may expand on this, but we don't actually fully understand the causes, really.

Probably multifactorial.

There's certainly associations with physical conditions, things like diabetes and thyroid disorders.

There is an association with hormonal imbalances, estradiol and testosterone, although the evidence is not as strong as one might think for testosterone.

Certain medications can be associated with hsdd, things like antidepressants and then psychological issues.

So anxiety, depression and current or previous relationship problems.

And Claire, you are a menopause specialist, and I think the question that lots of people are probably wondering about is, is this an issue amongst women who are going through perimenopause or menopause as well?

Yes, it's an incredibly common condition or symptom of the perimenopause and menopause.

And as Stephen said so brilliantly, there are so many reasons behind that.

So HSDD is obviously the far more severe end of the spectrum.

But depending on which study you read, anywhere between 40 and 60% will complain of.

Women will complain of low libido in the menopause, and obviously that then needs unpicking as to whether that's the more severe end of the spectrum or incredibly common.

And this does happen to men as well as women, I think it's worth calling out.

But in the menopause, a very common cause would be final symptoms.

So in the menopause, with the loss of estrogen.

Up to two thirds of women will develop vaginal dryness, soreness, irritation, lack of lubrication, painful or discomfort during intercourse.

And that can have a really significant impact then on libido.

And so there are some very specific causes related to the menopause.

Also, if we think about all of the myriad of symptoms of the menopause, so including hot flushes, night sweats, lower mood, low motivation, many women gain weight in the menopause.

Again, you can see how that then impacts and add to that anxiety, loss of resilience, you know, and the sort of more psychosocial factors.

Plus layer on top of that, often women have been in a relationship for many, many years.

You can see that there are additional challenges also.

So it's a really common and distressing issue.

And I think the question that maybe lots of gps will have, I think, is what are the current guidelines around using testosterone?

And Stephen, you mentioned the BMS guidelines, the British Menopause Society.

So what are the current guidelines telling us about using testosterone?

So if we think about the NICE guidance for menopause first, that's NG23 and that has been recently updated, the new Update published in November 2024.

And so nice say that testosterone can be used for low libido in the menopause in adequately estrogenized women.

So basically women on hrt, because actually HRT containing estrogen plus or minus progesterogen can be helpful in managing libido.

Libido and estrogen definitely has a really important part to play.

But NICE say that testosterone can be added if you've managed the vaginal symptoms, if you've managed menopause symptoms.

If women are taking hrt, then you can add testosterone.

On top of that, the British Menopause Society have really helpfully published guidance also, which goes into a little more detail on the practicalities of prescribing and monitoring.

And so the British Menopause Society would recommend that total testosterone is checked as a baseline and then pragmatically at around three months and then six to 12 months after that, again highlighting that this is predominantly prescribed for women on HRT and highlighting the importance of managing as much as you can the other symptoms that might be having an impact on libido.

Also, it can be really difficult because, as we both said, there are so many factors that can impact and sometimes you do have to take more of a pragmatic approach and manage symptoms as best you can.

Plus there may be a psychological aspect that needs to be approached through talking therapies plus testosterone on top of it.

So complex issues, complex answers, often multifactorial approach is needed.

And I guess what you've done here, as you mentioned, Stephen, was to develop local guidelines to help clinicians to guide testosterone testing.

And I'd recommend to people listening to take a look at the full paper, which will be linked in the show notes that give the specific guidelines that you've described and developed.

But can you give us a bit of a summary of what GP should be thinking about in terms of testosterone measurement?

Yes, I think probably the main point really is we'd certainly seen an increase in the number of advice and guidances from for secondary care about persistently raised testosterone in these individuals and what level should they be aiming for?

And the guidance is not quite clear currently, the BMS guidance, what the actual target values are.

Obviously, these will be lab dependent, which adds another layer of complexity to this.

But essentially what we thought we would do is try and look at general levels and say, well, if it's less than 75% of the lab reference range, then TRT could be trialled.

The other issue we get is, once the patient's on trt, what should they do if the level is persistently elevated, we feel that anything above 110% of whatever the lab range is would be too high and they should lower the dose and repeat two to four weeks after and continue that until you've got a level that's within the normal range or just above the normal range for your lab.

I think the other thing that we've definitely seen at Leeds is some very, very high levels.

So the normal range that we quote at Leeds is less than 1.8 nanomoles per liter.

Most of the patients that we're talking about here with, with higher levels between 2 and 4 nanomoles per litre, which is too high.

But we.

We get the odd1 that's 10, 11, 12 nanomoles per litre and we get phone calls or advice and guidance about this.

Now, at that level, it's.

It's potentially contamination from venipuncture site, although the advice is to put the gel on below the waist.

Often patients will apply it to the arm and if they apply it to the arm and then have a blood sample collected from the arm, you can get contamination from the venipuncture site and that's when you see levels of 10, 11, 12, 13.

Now, if you do see that, the advice, of course, is not to reduce the dose because the dose might be correct, it's to repeat it without the contamination to confirm the dose.

And I guess, as you've mentioned in your clinical practice paper, patients whose testosterone levels are perhaps too high would be experiencing significant side effects, I'd imagine.

I think it's really interesting because, as Steven said, sometimes the level is very high due to contamination and it is quite interesting.

You can get.

Obviously, if the level is truly very high, you are more likely to have side effects such as acne, like skin changes, hirsutism, additional unwanted hair, greasy scalp are the most common, although at the more severe end of the spectrum there can be virilisation and voice changes, but because it's frequently contamination and when you recheck it, it can be normal, there may not be side effects and you can actually get side effects from quite small increments of increase.

Everybody's very different in their sensitivity.

We know that the blood test for testosterone, which maybe will come on, isn't a perfect reflection of testosterone activity in the body.

The blood test measures the total testosterone, which is the sum total of the inactive protein bound, plus the very, very small free fraction of free testosterone.

And so the blood level of testosterone may not actually reflect activity of testosterone, which is why there's very poor correlation between an actual total testosterone level and clinical symptoms.

And it doesn't.

The blood level doesn't predict who will respond to testosterone or not.

And I think that the British Menopause Society have been pragmatic in that they've said, yes, measure a baseline just to make sure that the testosterone isn't on the high side before you add more in.

And then in monitoring, the aim is always to keep it within physiological limits.

For women, there doesn't seem to be a level that we have to aim for for a clinical response, but we do need to be safe and we do want to minimize the risk of side effects.

So it is very difficult because the evidence around this is very poor.

Because of the complexity of testosterone activity in the body, I wonder.

I think that quite a few gps might be.

Well, I.

I know that a lot of GPs are quite hesitant about prescribing testosterone, especially in women during the perimenopause or the menopause.

Claire, do you have any advice for GPs wondering if they should or can be prescribing testosterone to their patients?

Yeah, so that's a really good question.

In most parts of the country, and certainly in Leeds, testosterone is an amber drug.

So what that means is it's for specialist initiation only.

Now, some GPs are interested in the menopause and they've done additional training and are comfortable initiating testosterone and certainly once testosterone has been initiated by somebody, for example, like myself in the specialist menopause clinic or Dr.

Ward in endocrinology, they may then feel comfortable prescribing ongoing.

But if you're prescribing, you're taking responsibility for that monitoring.

And I think that's where the difficulty lies and that often GPs aren't confident because they haven't had training in their specialty.

Which is a reason why this paper's so good, because it's so clear of what to do.

They're not sure what to do when they get different levels of testosterone.

They're not sure to answer patient queries on it.

So the advice for GPs would be prescribe testosterone.

If you're comfortable, prescribe.

If you're comfortable monitoring.

There has to be a system in place for monitoring and reminding patients that they need these blood tests.

And we have a system in place with the specialist menopause clinic.

And if in doubt, ask, you know, always, always prescribe and practice within your comfort zone.

Really clear advice there, Claire.

Thank you.

Anything else either of you want to add about this area of prescribing or monitoring?

I mean, the only other thing I'd like to touch on really, is the.

The SHBG comment from the British Menopause Society.

So the British Menopause Society does reference SH measurement.

So, as Claire alluded to earlier, SHBG is the binding protein for testosterone.

And what we found in the audit data was that out of 100 patients we looked at, SHBG was only measured about 11 times.

But in only one case did it add any clinical value.

And I think there's a significant lack of understanding about how SHBG will actually add any value to the measurement of a total testosterone.

So our advice really is that at the minute, there's probably not enough evidence to routinely measure SHBG in these patients.

Potentially in ones that are difficult to manage or where there's a poor correlation between testosterone concentration and clinical effect, SHBG might be worth measurement measuring.

After discussing with kind of the local experts or the duty biochemistry.

I think just hearing that is really bringing to the forefront why this collaboration between yourself as a clinical biochemist and GPs is why this paper is really valuable, because it's bringing that expertise about measurement of testosterone and also the clinical use of it.

So that's been really interesting to hear, but I guess, yeah, that's been a really great chat around this area.

And as I said, I hope people will go back to read the paper just for the full details of the guidelines that you have suggested in in that.

But as an area that's probably of increasing importance in general practice prescribing, I think it's been a really useful paper to talk about.

So yeah, I just wanted to say thank you very much for your time.

Thank you, thank you.

And thank you all very much for your time here and for listening to this BJDP podcast.

Stephen and Claire's original clinical practice article can be found on bjgp.org and the show notes and podcast audio can be found@bjgplife.com I hope you found today's podcast helpful.

I certainly know that it will help me in the future in terms of guiding my decisions around initiating and monitoring testosterone in women, especially around the perimenopause or menopause.

Thanks again for listening and bye.