Menopause
World’s first testosterone patch for menopause to begin clinical trials
The treatment could “transform” the life of women suffering from menopause symptoms globally, say experts
Researchers in the UK are to test the world’s first testosterone patch for menopause in a move that could have a “huge” potential to improve women’s lives.
Testosterone is an essential hormone for women and its production drops heavily after menopause.
Whilst oestrogen and progesterone HRT patches are available, women who find menopause impacts their libido can’t be prescribed testosterone on the NHS, leading some to resort to treatments only approved for use on men.
Medherant, a company founded by University of Warwick’s Professor David Haddleton, has raised almost £3m of to develop the pioneering testosterone patch and is preparing to launch clinical trials this autumn.
Assuming trials go well, the treatment could become the only testosterone replacement patch available globally and introduced first in the UK.
“This is a very exciting development for us – the potential of this technology to improve women’s lives is huge,” says Haddleton, Professor of chemistry at the University of Warwick and Medherant’s founder.
“The work we’re doing at Medherant and at Warwick isn’t just theoretical, but instead aimed at a problem women are facing which can drastically affect their everyday lives and jobs.”
“This could deliver a product that is much needed and is just not available. With the technology already proven to work we can use our new patch to remove needless misery from women’s daily lives.
“We hope this will transform life for those suffering from post-menopause issues nationally, and indeed globally.”
Since 2015, menopause guidelines issued by National Institute for Health and Care Excellence (NICE) recommend that testosterone supplementation be considered for women with low sexual desire if hormone replacement therapy alone is not effective.
The new patch intends to address the gap in menopause products, providing specific treatment that can be made widely available to women seeking treatment.
John Burt, CEO of Medherant, said: “Having the funding in place for the first clinical trial of our testosterone patch for post-menopausal people will enable Medherant to take a major step towards registration of the product and being able to address this significant gap in the options available for those in this very important stage of their lives.”
Menopause
Round up: First wearable detects symptoms of perimenopause, and more
Femtech World explores the latest business developments in the world of women’s health.
First wearable detects and decodes the symptoms of perimenopause
AI-driven women’s health company, IdentifyHer, has launched Peri, the world’s first wearable designed to detect and decode symptoms of perimenopause.
“75 per cent of perimenopausal women experience life-disrupting symptoms, yet perimenopause is treated like a mystery or an inevitability that women simply have to power through,” said Heidi Davis, co-founder of IdentifyHer.
“We reject this. Women deserve real data, validation, and support during this profoundly overlooked stage of life
“With Peri, we are pioneering a new era of women’s healthcare; one where women are in control of their health and equipped to manage the symptoms that shape how we feel – physically, mentally and emotionally.”
For most women perimenopause begins in the early to mid-40’s and brings wide-ranging symptoms that are often dismissed by healthcare providers.
Using biosensing technology and AI-driven analytics, Peri is a wearable device that passively tracks physiological signals to identify perimenopause symptoms and delivers personalised insights.
It helps women address perimenopausal challenges like anxiety, hot flashes, sleep disruption, nights sweats and more – issues that could have long-term health implications.
The device profiles these symptoms across the menstrual cycle, examining their interrelationships, and tracking changes over time.
“Heidi and I first launched IdentifyHer with the mission to support women’s long-term health, and immediately recognised that to do this, we need to address the gap in perimenopause symptom data,” said Donal O’Gorman, COO and co-founder of IdentifyHer.
“Our goal with Peri is to demystify perimenopause, but more importantly, to empower and reassure women they are not alone in what they’re feeling and it is possible to take proactive action towards their health.”
Emm raises £6.8m to launch world’s first smart menstrual solution
UK-based biowearable tech company, Emm, has raised £6.8m in an oversubscribed seed funding round, to bring the world’s first smart menstrual cup and connected app to market.
Creating a new category of “smart menstrual care”, Emm will equip users to understand their individual menstrual baseline and track key metrics for personalised insights into their menstrual health.
The funding will support Emm in bringing the product to market and accelerating the pathway to further clinical product development, as the business moves to transform the research, diagnosis and treatment of reproductive and menstrual health conditions.
Results published on potential endometriosis treatment
Biotech company Hope Medicine has announced that the results of a proof-of-concept Phase II clinical trial evaluating HMI-115 (a human monoclonal antibody targeting the prolactin receptor) for the treatment of endometriosis-related pain have been published in The Lancet Obstetrics, Gynaecology, & Women’s Health.
The research, carried out in collaboration with Peking University, Peking Union Medical College Hospital, Shandong University, and other institutions, aimed to evaluate the safety, tolerability, and preliminary efficacy of HMI-115 in premenopausal women with moderate to severe endometriosis-related pain.
Results showed that at the end of the 12-week treatment period, dysmenorrhea NRS scores decreased by 41 per cent, 34 per cent, and 27 per cent in the 240 mg, 120 mg, and 60 mg HMI-115 groups, respectively, compared to the 18 per cent reduction in the placebo group.
Non-menstrual pelvic pain NRS scores also decreased across all HMI-115 dosage groups, with sustained efficacy observed at Week 25.
The company says that percentage reductions of dysmenorrhea and non-menstrual pelvic pain in the 240 mg group was statistically significant compared to placebo.
Additionally, HMI-115 groups showed improvements in the Endometriosis Daily Impact Pain (EDIP) scores and reduced use of NSAID rescue medications.
In terms of safety, the incidence of treatment-emergent adverse events (TEAEs) was 56 per cent, 59 per cent, 75 per cent, and 37 per cent in the 60 mg, 120 mg, 240 mg HMI-115 groups, and placebo group, respectively.
The most common adverse events included injection site itching and rash, dizziness, nausea, nasopharyngitis, and headaches.
No treatment-related deaths or serious adverse events were reported. Unlike existing hormonal therapies, HMI-115 did not cause hypoestrogenic side effects such as hot flashes or depression, and bone mineral density and key sex hormone levels remained stable during treatment.
This study is the first to clinically validate the potential of blocking prolactin receptor signaling to alleviate endometriosis-related pain.
Its non-hormonal mechanism of action avoids interference with ovulation and menstrual cycles, offering a promising new option for patients with fertility intentions.
The research team stated that these findings provide a strong foundation for initiating longer-duration Phase III trials to further evaluate the clinical benefits and risks of HMI-115.
A month of milestones in breast imaging innovation
Koning Health has said that October marked a substantial month for Koning in its mission to expand access to non-compression breast imaging.
The last several weeks saw the continued expansion of Koning’s technology to new and diverse settings across the country, including the official launch of Gnosis Dx, which introduced a mobile breast imaging and diagnostics platform powered by the Koning Vera Breast CT (KBCT) on the West Coast.
Designed to travel directly into communities, the Gnosis trailer is meant to reduce barriers to early detection and address disparities in access in the state of California.
On Manhattan’s Upper East Side, Pink Medical celebrated its grand opening this month with a ribbon-cutting event led by fashion icon Nicole Miller. This New York City location aims to redefine the breast imaging scene in the Big Apple.
Koning’s installation at Mount Sinai Medical Center in Miami brought the Vera system to one of Florida’s most respected medical institutions.
The device will be used both clinically and for research, advancing the understanding of breast CT’s role in precision detection and patient-centered imaging.
Koning continues to expand its international reach as the only breast CT manufacturing company that has received global critical regulatory and quality achievements including Koning’s 3D breast imaging system remains the only FDA-approved breast CT device commercially available for diagnostic use in the US.
The company is also seeing progress advancing in Australia (TGA) and through Europe’s GMED for CE Mark.
Menopause
Snoring, silence, and the menopause taboo: The hidden health crisis affecting millions
By Professor Ama Johal, clinical lead and dental sleep expert at Aerox Health
During menopause, it’s very common for women to notice significant changes to their sleep patterns and experience things like restless nights, loud snoring, or simply waking up feeling exhausted.
What most don’t realise, however, is that these symptoms can signal something far more serious – obstructive sleep apnoea (OSA), one of the most impactful and consequential sleep-related breathing disorders.
Women across the world are unknowingly fighting an uphill battle. Around 90 per cent of females with moderate to severe sleep apnoea remain undiagnosed.
This collective lack of awareness is due to a plethora of factors including archaic taboos around the subject and lack of education or omission of menopause in sexual education.
Ultimately, this combination leaves women underprepared and vulnerable to the biological, social and medical realities associated with the menopause.
Now more than ever, we must confront this silence head-on and recognise the hidden sleep crisis affecting so many women globally and the opportunity to address it.
The hidden sleep crisis
Snoring that develops or worsens during menopause can progress into OSA due to a decline in estrogen and progesterone which reduces muscle tone in the throat and in turn makes the obstruction or collapse of the airways more likely during sleep.
Yet this link between menopause and sleep disorders remains largely overlooked, leaving millions of women undiagnosed, untreated, and unaware that their sleep struggles are more than just “part of getting older”.
In my practice, I see the consequences of this misunderstanding far too often.
I hear from many female patients who have been suffering in silence, without the knowledge that they could seek help. In fact, I often encounter the common misconception that snoring is a man’s issue.
This preconceived notion perpetuates a persistent gender bias in sleep-related health research.
As ENT consultant and sleep surgeon at University College London hospitals, Ryan Chin Taw Cheong recently highlighted, the development of snoring is reason enough to consult your doctor. It’s time for this pervasive issue to emerge from the dark.
So why don’t women seek help?
When considering why many women do not seek help for their symptoms, there are two overarching reasons.
Firstly, the information and knowledge is not widely available for sufferers to realise that snoring can be a medical issue which can be assessed and subsequently readily treated.
Secondly, there is a potent stigma surrounding both the menopause and snoring which is an inhibiting factor amongst sufferers, discouraging open discussion.
Perhaps unsurprisingly, menopause is not included in traditional sex education in schools. Being unaware of what is ‘normal’ and what could require medical attention is widespread amongst my patients with sleep disorders, yet this information is not freely disseminated outside of clinics.
Unfortunately, cognitive fog and irritability – symptoms of snoring and obstructive sleep apnoea – are too often written off as stress, anxiety or ‘just the menopause’.
Avoiding sharing symptoms with medical providers, combined with online misinformation, often results in individuals suffering in silence or worse, turning to unregulated miracle menopause cures that exacerbate the risks of undiagnosed OSA.
These so-called ‘cures’ reinforce the harmful notion that the menopause is a defect which needs to be fixed rather than a natural life stage.
The health costs of ignoring snoring
A breadth of research links untreated OSA to cardiovascular disease, hypertension and cognitive decline.
However, aside from the medical risks, snoring and sleep apnoea can have profound social and emotional consequences.
For women, the shame in snoring, a symptom often mischaracterised as a ‘male issue’, can significantly affect self esteem and mental health.
Partners may also suffer if the snoring is disruptive to their sleep, in some instances causing rifts in relationships and a phenomena known as ‘sleep divorces’ (sleeping in separate beds or rooms).
In fact, according to a recent study commissioned by 32Co, 47 per cent of recently divorced Brits cite interrupted sleep linked to snoring or sleep disorders as contributing to their relationship breakdowns, with 85 per cent believing ‘sleep divorces’ contributed to ultimate separation.
Sleep specialists seek to manage and monitor the symptoms of sleep disorders and OSA to minimise disruption to an individual’s personal and public life.
Screening menopausal women for OSA is a preventative measure which leads to informed patients. It is not simply about getting better sleep but about the long-term health outcomes.
Breaking the silence: what needs to change
Drawing on the stories of those I meet in my clinic, I would like to outline five steps that we can take to address this silent epidemic.
First, the menopause and associated symptoms should be included in a comprehensive sex and health education.
This could be provided both in schools’ curricula and made readily available at health services catering to adults.
Second, throughout the course of history women’s issues have been chronically underserved.
More resources can be funnelled into conducting research to help us better understand the impact of the menopause on women’s physical and mental health.
Future research would also help to neutralise the gender bias of previous studies.
Third, launching public health campaigns and workplace initiatives to encourage employers to recognise sleep disorders as a significant element of menopause will help build awareness and reduce the impact of stigmas.
Fourth, myth-busting, shattering taboos, and normalising discussion about the menopause will be key.
We must view snoring as a gender neutral issue rather than a male stereotype and denounce harmful rhetoric and jokes that perpetuate stigma.
Fifth, we must better equip more localised healthcare providers up and down the country to both diagnose and treat OSA effectively.
Sleep disorders are not niche issues but a major public health concern with potentially severe consequences.
Quality of life amongst my patients is inextricably linked with sleep quality.
Recognising the relationship between snoring and OSA and the menopause is not simply about pathologising a natural stage of life, but providing women with the information, respect and medical care they deserve.
Only through more transparency and collaboration amongst researchers, educators and clinicians can we hope to close the gender gap in sleep medicine and bring this hidden crisis to light.
Insight
Round up: Restoring immunity in menopausal women with HRT and more
Femtech World explores the latest research developments in the world of women’s health.
Phase 2 trial of non-hormonal endometriosis treatment completed
Hope Medicine has completed a global Phase 2 study evaluating the safety and efficacy of non-hormonal endometriosis treatment – HMI-115.
HMI-115 is a monoclonal antibody that blocks the prolactin receptor, and is a potential first-in-class treatment for endometriosis.
This study included 108 female patients with surgically diagnosed endometriosis in the US, Poland and China.
According to the company, the treatment demonstrated statistically significant improvement of endometriosis associated pain.
HMI-115 was well-tolerated with no treatment-related serious adverse events.
Specifically, at the end of the study treatment, the least-square-mean dysmenorrhea pain score was reduced by 42 per cent in the 240 mg q2w group, compared to that of the baseline.
The least-square-mean non-menstrual pelvic pain score was reduced by 52 per cent.
These reductions are statistically significant. No typical peri-menopausal symptoms were reported.
There were no significant changes in menstrual patterns, bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone.
Lan Zhu, director of gynecology at Peking Union Medical College Hospital and leading investigator of the study, said: “HMI-115 relieved endometriosis pain in women without disturbing their sex hormones.
“It can potentially shift the treatment paradigm.
“We will be able to treat women without menopausal side effects or even infertility.”
Nathan Chen, CEO of Hope Medicine says that the company is now communicating with key regulatory agencies, including FDA and NMPA, to finalise the Phase 3 protocol and to initiate global Phase 3 studies.
Hormone replacement therapy may help restore immunity in menopausal women
Hormone replacement therapy (HRT) may help reverse changes in the immune system caused by menopause, potentially booting immune health, a new study has found.
The research reveals new evidence that menopause significantly alters women’s immune system, increasing their vulnerability to infections.
The study is the first detailed analysis of how ageing and sex differences influence monocytes, a key group of immune cells that act as the body’s first responders to infection.
Analysing blood samples, the team found that after menopause, women develop more inflammatory types of white blood cells called monocytes, which are less effective at clearing bacteria.
These changes were linked to lower levels of complement C3, an immune protein that helps monocytes engulf and destroy harmful microbes.
In contrast, men of the same age did not show these changes, suggesting menopause has a uniquely disruptive effect on female immunity.
To test whether hormone therapy could influence this decline, the researchers studied peri-and post-menopausal women taking HRT.
They found that these women had healthier immune profiles, with fewer inflammatory monocytes and stronger infection-fighting ability as compared to age-matched controls.
Levels of complement C3 in their blood were also higher in those taking HRT, bringing them close to the immune status of younger women.
HRT is already prescribed to manage symptoms, but this study suggests it may also help maintain immune health and reduce infection risk in later life.
The researchers caution, however, that more work is needed to confirm whether HRT reduces real-world infection rates, and to understand how different formulations or delivery methods affect the immune system.
The authors caution that while the findings are promising, the study does not mean HRT should automatically be prescribed for immune health.
More research is needed to confirm whether women taking HRT have lower infection rates in real-world settings, and to investigate how different types and route of HRT administration may affect the immune system.
New imaging technique helps us understand how eggs mature and ovaries age
The ticking of the biological clock is especially loud in the ovaries — the organs that store and release a woman’s eggs.
From age 25 to 40, a woman’s chance of conceiving each month decreases drastically.
For decades, scientists have pointed to declining egg quality as the main culprit.
But new research from UC San Francisco and Chan Zuckerberg Biohub San Francisco shows that the story is bigger than the eggs: The surrounding cells and tissues of the ovary play a crucial role in how eggs mature and how quickly fertility wanes.
Understanding these changes may hold the key not only to extending fertility, but also to improving health.
The risks of many age-related diseases rise after menopause or ovary removal, and slowing ovarian aging could help reduce these risks.
The team set out to profile what normal ageing looks like in the ovaries of mice and humans.
First, they developed a new three-dimensional imaging technique that allowed them to visualise eggs in the ovaries without having to slice the organs into thin layers, as had been done before.
In mice that were the equivalent of 30 to 40 human years, they observed a dramatic drop in both immature resting eggs that are waiting in reserve and in growing eggs that are beginning to mature for ovulation.
And just like women in their 30s, the mice did not conceive easily with in vitro fertilisation (IVF).
When the scientists extended their 3-D imaging to human ovaries, they uncovered an unexpected finding: Eggs are not evenly scattered throughout the ovary.
Instead, they cluster in “pockets” surrounded by egg-free zones. With age, the density of eggs within these pockets declines.
“This was a surprise, we assumed eggs would be distributed more evenly based on what we see in the developing ovary,” said Laird, who is a Biohub investigator and a member of the Eli and Edythe Broad Center for Regeneration Medicine at UCSF.
“These pockets suggest that even within one ovary, the environment around an egg may influence how long it lasts and how well it matures.”
Next, the researchers teamed up with Neff’s group at the Biohub to study what genes were active in ovary cells as they aged.
Ovarian tissue from humans is hard to come by, and eggs are large and incredibly fragile.
So, instead of using standard miniature devices that separate and tag cells to sequence their active genes, the group painstakingly isolated individual eggs by hand to separate them from other cells.
After studying nearly 100,000 mouse and human cells, they identified 11 major cell types found in the ovaries, including one surprise: Glia, a type of support cell typically associated with nerves and most extensively studied in the brain, were in the ovaries.
At the same time, the study revealed that sympathetic nerves, the same nerves involved in the “fight or flight” response, form dense networks in ovaries that become even more dense with age.
When the researchers ablated these nerves in mice, the animals had more eggs in reserve but fewer that matured, suggesting the nerves help decide when eggs start growing. Together, the observations on glia and sympathetic nerves suggest a new role for the nervous system in ovarian health.
Other support cells called fibroblasts also changed with age, triggering inflammation and scarring in the ovaries of women in their 50s, years earlier than such scarring appears in organs like the lungs or liver.
“This all points to a brand-new line of inquiry about how nerves, blood vessels, and other cell types communicate with eggs,” Laird said.
“It tells us that ovarian ageing is not just about the egg cells but about their whole ecosystem.”
The new roadmap of healthy ovaries over time offers a starting place to ask how ovarian aging changes in different situations.
The team is already launching studies probing whether some drugs could change the timing or speed of ovarian aging, she said.
Ultimately, they hope to uncover ways to slow or delay ovarian aging, to impact both fertility and other diseases, like cardiovascular disease, which are common in women after menopause.
“The fountain of youth may actually be the ovary,” said Eliza Gaylord PhD, a postdoctoral fellow at UCSF who is co-first author of the study.
“Delaying ovarian ageing could promote healthier aging overall.”
Hormonal birth control can influence emotions and memory
A new study shows that hormonal contraceptives appear to shape how women experience emotions in the moment and how they remember emotional events later.
Researchers compared women using hormonal contraceptives with women who were naturally cycling.
Participants viewed positive, negative and neutral images while applying different emotion regulation strategies, such as distancing, reinterpretation or immersion, and later completed a memory test.
Women on hormonal contraceptives showed stronger emotional reactions compared to naturally cycling women.
When they used strategies like distancing or reinterpretation, they remembered fewer details of negative events, though their general memory remained intact.
In other words, they could recall the overall event but not all of the specifics. That gap may actually be helpful, allowing women to move on instead of replaying unpleasant details.
Strategies like immersion boosted memory for positive images in both groups, making happy moments stick more clearly.
The findings add weight to a question many women have had but few studies have answered: How does birth control affect not just the body but the mind?
Emotion regulation and memory are tied to mental health outcomes such as depression, and this research suggests hormonal contraceptives may influence those processes in subtle but meaningful ways.
The researchers plan to expand the work by studying naturally cycling women across different menstrual phases and by comparing types of hormonal contraceptives, such as pills versus IUDs.
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