Clinical trials? What’s the big deal?

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When we say that Hyalofemme has been clinically proven, what does that actually mean, and why does it matter?

It’s important because it’s not good enough to say ‘This substance has moisturising properties, so it will relieve symptoms of vaginal dryness’. In a more extreme example, you could say ‘Bleach has cleansing properties, so it will be good as a vaginal wash’. 

Ingredients may be natural and even organic, but that doesn’t mean they are safe to use in your body – especially such a sensitive part.

Stinging nettles are natural – you wouldn’t want to rub them on your vulva, even though they lose their sting when steeped and make a lovely soothing tea. 

Organic certification provides an assurance about how the ingredient has been grown, not how it interacts with your body. 

A CE Mark simply tells you that the commercial product complies with trading laws in Europe.

Proof that it works, proof that it doesn’t harm you

When it comes to vaginal moisturisers, you need proof that it works and proof that it doesn’t cause harm

You can only get that with approved clinical trials, which have been carried out using the complete formulation of the product (not just individual ingredients). These studies are then published in peer-reviewed scientific journals which are kept on file, so that healthcare providers can refer to them. The references for Hyalofemme are below.

Hyalofemme is the ONLY non-hormonal vaginal moisturiser (NHVM) which has been tested in clinical and pre-clinical trials to make sure that it keeps cells in your vagina plumped up with moisture for up to three days, and that it’s safe to use, in:

  • menopausal women
  • women who are having cancer treatment
  • women who have had cancer
  • new mums
  • women who use the contraceptive pill

So, when we say that Hyalofemme has been clinically proven to be as effective as vaginal oestrogen cream, it means that two groups of women were studied – one group used oestrogen and the other used Hyalofemme. Doctors examined them at regular intervals physically to check the condition of their vaginal tissue, and used specially scientifically validated questionnaires to assess how much their symptoms had been relieved and how they felt about that.

Results for oestrogen and Hyalofemme groups were as good as each other. That means your vagina can get all the goodness it needs from Hyalofemme – which is important for women who have been advised not to use hormones, and those who prefer to avoid them.

Here’s what you need to know about the superior scientific process that only Hyalofemme has been through…

Why is a clinical trial like a sponge cake?

In your sponge cake, you mix all the ingredients in a bowl, then put the concoction in the oven. If you change the mixture, different things happen in the oven and it changes the results. Two eggs, three eggs, vegan egg replacements, more or less flour or sugar, cocoa, dairy or vegan butter. They all affect what happens when you mix and bake them.

It’s not dissimilar when you’re making a vaginal moisturiser.

Pre-clinical trials help you decide what ingredients might be useful. But you can’t assume they will work together, or that they will work when you put them into a human body. You need to understand what happens when the mixture you’ve made goes into the body.

When you put a substance into your body, your body does something with it, over time, like a cake in the oven. What you breathe in, eat or put on your skin can either help you or harm you, and it won’t always be immediately obvious.

In Hyalofemme clinical trials, women were monitored after one month, three months and six months. Physical examinations were carried out to measure how much the condition of the vaginal tissue had improved, and to check if there had been any adverse reactions or discomforts.

Other scientifically approved tests measured:

  • how much and how quickly women’s symptoms of itching, burning, pain and odour had resolved
  • improvements in women’s desire for sex and their ability to enjoy it
  • whether there were changes in vaginal acidity

All of the results showed that Hyalofemme helped to resolve the symptoms of vaginal dryness such as itching, burning, and pain. One trial proved that Hyalofemme was as effective as oestrogen cream.

Some of the Hyalofemme clinical trials also measured female sexual function, because vaginal dryness can result in pain that means women start avoiding intercourse. This can lead to more complex problems such as sexual dysfunction and relationship breakdowns.

Results from the trials showed marked improvements in the women’s ability to have sex, and their desire to do so.

Are pre-clinical and clinical trials required for vaginal moisturisers?

No. It’s actually not illegal for anyone to whisk up their own cocktail of ingredients, pop them into an attractive pot or tube, and sell them. There are some regulations about what they put on the label, but that’s about it.

Even then, there’s a big question mark about the terms ‘lubricant’ and ‘moisturiser’ on the label (see our infographic here for more on that).

A vaginal moisturiser ought to have evidence that does more than just adds some moisture to the vagina, or lubricate (meaning that temporarily coats the tissue in a liquid to prevent friction).

And by evidence, we mean clinical trials where the complete formula of the product was properly measured, in humans.

What’s safer: a hunch or scientific testing?

Pre-clinical trials are done in a laboratory. They help scientists to figure out whether the ingredients that seem like they could work are actually effective.

Experiments are carried out on the product, or one of its ingredients, in a test tube or petri dish. These trials yield preliminary information about efficacy, toxicity and safety.

They help scientists decide whether to carry on to the next stage of testing.

What’s different about clinical trials?

A clinical trial means that the product has been tested on living humans, in controlled circumstances to measure the effects.

Clinical trials can test for all sorts of outcomes – for instance:

  • to ensure that the substance works and that it’s safe
  • to compare one product with another product
  • to compare what happens with people who use the product, with those who don’t

Clinical trials can be carried out with individual ingredients, and/or with the finished formula containing a number of ingredients. There is evidence from both types for Hyalofemme.

Clinical trials on individual ingredients only give you a very small part of the overall picture.

For instance, Hyalofemme is made with hyaluronic acid, a substance which is known to be moisturising. It occurs naturally in various parts of the body, including the vagina, to keep the tissues moisturised and lubricated to prevent friction where there is movement, like in joints, eyes etc.

It makes sense to use hyaluronic acid in a vaginal moisturiser. So the manufacturer set about pre-clinical trials. In this process, they discovered that the best type of hyaluronic acid for the vagina was Low Molecular Weight (LMW). They found a way to produce this LMW version which is optimal for the vagina to use the moisture it contains, and patented it – it’s called Hydeal-D®.

So, they knew they had one fantastic ingredient for a vaginal moisturiser. But they couldn’t assume it would work in a women who was suffering with vaginal dryness. Especially considering they had to added other ingredients to make it into a gel which could sit on a shelf for months without the need for parabens or other nasty ingredients to act as preservatives and stabilisers.

How do you eliminate assumptions? Clinical trials!

The fact is, individual ingredients react in different ways with other substances. And those substances include what your body is made of.

If you haven’t tested the actual formula, you have no idea how good or bad it’s going to be when you put all the ingredients together and put it into someone’s body. It’s really nothing more than an assumption. Guesswork.

Hyalofemme is the ONLY non-hormonal vaginal moisturiser which has been tested in clinical and pre-clinical trials to make sure that it works, and that it’s safe to use, in:

  • menopausal women
  • women who are having cancer treatment
  • women who have had cancer
  • new mums
  • women who use the contraceptive Pill

The results of these clinical trials are that the women who used Hyalofemme got significant relief from the symptoms of vaginal dryness, and their sexual function improved.

What have peers got to do with clinical trials?

To have credibility, clinical trials need to be published in peer-reviewed scientific journals.

This means that the scientists and doctors who conducted the clinical trial wrote up the results, and submitted the paper to a journal.

This process is rigorous. A study can only be published when several experts in the field (the peers) examine the methods used for testing, and the results.

These experts are uncompromising and unforgiving as they examine the data. They’re a real nuisance to the get-rich-quick crowd.

They can challenge any aspect of the study, such as:

  • the type of people who were recruited
  • the methods for testing
  • the materials used
  • the ways that results were measured
  • things that should have been done as part of the trial but weren’t
  • the ways the results were analysed and presented
  • the conclusions that were reached

Only when they are satisfied that the results stand up to the challenges can the study be published.

Are there different levels of clinical trials?

Yes. The requirements for testing vary according to how the product is classified. It’s most strict for pharmaceutical drugs, and least strict for cosmetics. Vaginal moisturisers are in a classification somewhere in between, called medical devices.

Nevertheless, the clinical trials for Hyalofemme are the same standard as pharmaceuticals.

Why is it worth bothering with all this?

It’s the only way to be sure that you’ve got a high-quality product that works properly.

You may know that a substance moisturises your face or body, but that doesn’t mean it moisturises your vaginal tissue. It’s an entirely different environment in there. And even if it feels nice on your external skin, it could irritate your vagina.

For instance, Hyalofemme contains hyaluronic acid (HA), which is used in many facial moisturisers. But it’s made by a world-leading specialist in HA. So rather than assuming that HA would OK in the vagina, they set about discovering the best way to use HA in the vaginal environment.

Through thorough testing, they discovered that Low Molecular Weight (LMW) HA was even more moisturising than standard HA when it was used in the vagina. They patented this version, called Hydeal-D.

There is also trial evidence that it adheres to the vaginal tissue for around three days, which is one of the reasons Hyalofemme has a long-lasting effect. Another reason is a process called enzymatic breakdown. Hydeal-D resists this, meaning that it releases its moisture more gradually, allowing it to rehydrate the tissue over several days (depending on how dry the tissue is).

Why don’t all NHVMs bother with clinical trials?

You’d have to ask them. One reason could be that all of this testing, writing papers, and going through the publication process is expensive and time-consuming.

We think it’s worth it.

We want to be absolutely certain that we are giving you a high quality vaginal moisturiser which will relieve your symptoms without doing any harm.

What’s a CE Mark, or UKCA Mark?

A CE Mark or UKCA Mark should be on all vaginal moisturisers as proof that it complies with trading laws. It’s a completely different thing to a clinical or pre-clinical trial.

Manufacturers or importers can place a CE (Conformité Européenne) Mark on any commercial product – from electrical goods to toys to medical devices. It is primarily to indicate that it can be traded freely anywhere in the European Economic Area, regardless of its country of origin.

The product simply needs to pass an assessment that it conforms to EU laws. It does not mean that the product has been passed as safe.

The conformity assessment usually involves an audit of the manufacturer’s quality system and sometimes a review of technical documentation from the manufacturer.

The UKCA (UK Conformity Assessed) mark is the UK’s post-Brexit product mark for goods sold in England, Wales, and Scotland. Northern Ireland also uses a UKNI mark.

What are GMP and GDP how do they help?

Not all NHVMs are made by manufacturers that also produce medicines. Hyalofemme is, and this ensures that you get a product which is covered by these three additional levels of quality control. They involve audits and inspections by medical governing bodies.

  • Good Manufacturing Practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes.
  • Good Distribution Practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.

What are the references to Hyalofemme clinical trials?

A reference is how you can get more detail. It allows you to find the paper that was published in the scientific journal.

Again, it’s important to know the difference between a published study on a product’s ingredient, and a study in which the actual product has been tested, to see how all the ingredients react together, and in the human body.

Here are some of the more important references for Hyalofemme:

  1. Nappi, R.E. et al. (2022) Treatment of vulvo-vaginal atrophy with hyaluronate-based gel: A randomized controlled study. Minerva Obstetrics and Gynecology. 74(6).
  2. Gustavino, C. et al. (2021) Efficacy and safety of prolonged-release hyaluronic acid derivative vaginal application in the postpartum period: A prospective randomised clinical trial. Annals of Medicine, 53(1), pp. 1589–1597.
  3. Carter, J. et al. (2020) A single-arm clinical trial investigating the effectiveness of a non-hormonal, hyaluronic acid-based vaginal moisturizer in endometrial cancer survivors. Gynecologic Oncology, 158(2), pp. 366–374.
  4. Carter, J. et al. (2020) A single-arm, prospective trial investigating the effectiveness of a non-hormonal vaginal moisturizer containing hyaluronic acid in postmenopausal cancer survivors. Supportive Care in Cancer, 29(1), pp. 311–322.
  5. Advani, P. et al. (2017) A pilot randomized trial to prevent sexual dysfunction in postmenopausal breast cancer survivors starting adjuvant aromatase inhibitor therapy. Journal of Cancer Survivorship, 11(4), pp. 477–485.
  6. Liu, S.-B. et al. (2014) The effects of hyaluronic acid vaginal gel on vaginal epithelium. Gynecological Endocrinology, 31(3), pp. 208–213.
  7. Chen, J. et al. (2013) Evaluation of the efficacy and safety of hyaluronic acid vaginal gel to ease vaginal dryness: A multicenter, randomized, controlled, open-label, parallel-group, clinical trial. The Journal of Sexual Medicine, 10(6), pp. 1575–1584.
  8. Dusio et al, (2011) Stimulation of TLRs by LMW-HA induces self-defense mechanisms in vaginal epithelium. Immunology and cell Biology 89, 630-639
  9. Dusio, G.F. et al. (2010) Stimulation of tlrs by LMW-HA induces self-defense mechanisms in vaginal epithelium. Immunology & Cell Biology, 89(5), pp. 630–639.
  10. Gariboldi, S. et al. (2008) Low molecular weight hyaluronic acid increases the self-defense of skin epithelium by induction of -defensin 2 via TLR2 and TLR4. The Journal of Immunology, 181(3), pp. 2103–2110.
  11. Sandri, G. et al. (2004) Mucoadhesive and penetration enhancement properties of three grades of hyaluronic acid. Journal of Pharmacy and Pharmacology, 56(9), pp. 1083–1090.
  12. Campoccia, D. (1998) Semisynthetic resorbable materials from Hyaluronan esterification. Biomaterials, 19(23), pp. 2101–2127.
  13. Tempera, G. (1998) Evaluation of tolerability and efficacy of HyaloGyn Vaginal Gel for the treatment of vaginal dryness and irritation. Data on file at Fidia Farmaceutici S.p.A. 29.
  14. Sanzgiri, Y.D. et al. (1994) Evaluation of mucoadhesive properties of hyaluronic acid benzyl esters. International Journal of Pharmaceutics, 107(2), pp. 91–97.

Featured photo: iStock

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Clinical trials? What’s the big deal?
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