Menopause
Hydrogel offers hormone-free relief for menopause symptoms
A hydrogel applied to vaginal tissue could offer hormone-free relief for menopause symptoms, new research suggests.
The treatment may help with vaginal dryness and pain linked to genitourinary syndrome of menopause (GSM).
GSM occurs when the vaginal and urinary tissues become thinner and drier after menopause.
Dr Marianna Alperin, professor and vice chair for translational research in the Department of Obstetrics, Gynaecology, and Reproductive Sciences, said: “An estimated 47 million women in the US become menopausal every year, thus GSM represents a major public health issue that urgently needs investment.”
GSM affects up to 85 per cent of women over 40.
Between 30 and 60 per cent experience vaginal dryness and pain, which can disrupt sleep, sex life and daily activities.
Around 65 per cent of women with GSM report dissatisfaction with current treatments.
During menopause, vaginal tissues thin, blood vessels and connective tissue shrink, and smooth muscle layers weaken.
These changes affect the vagina’s ability to expand during sex and to support organs such as the bladder, uterus and rectum. Immune cells also begin producing inflammatory proteins.
The main treatment now is low-dose vaginal oestrogen, which thickens the vaginal lining but does not restore deeper smooth muscle tissue.
Some patients and doctors avoid this therapy because of concerns about hormone-sensitive cancers, despite research suggesting these fears are not supported.
The therapy is also expensive and not always covered by insurance.
The researchers previously developed hydrogels for cardiac repair that were tested in a Phase 1 FDA-approved clinical trial.
The team then partnered with Alperin’s group to explore hydrogel use in GSM.
The team tested the hydrogel on 24 menopausal rats.
They applied daily doses at two strengths (6 or 8 milligrams per millilitre) alongside collagen or saline controls.
After 14 days, vaginal tissue treated with hydrogel resembled pre-menopausal tissue.
Smooth muscle thickness increased, especially with the higher dose, likely because of the higher concentration of extracellular matrix proteins.
The hydrogel reached both surface and muscle layers of the vaginal wall within three days.
Macrophages – immune cells that aid tissue repair – responded positively.
Images of treated tissue showed hydrogel-treated samples resembled healthy tissue, unlike saline or collagen controls.
Emma Zelus is first author of the study and preclinical research manager at the Sanford Stem Cell Institute.
She said: “We are not looking to replace oestrogen treatments.
“We want to provide an alternative for patients and physicians who either do not want to use hormone-based therapy or for women for whom vaginal oestrogen alone is insufficient.”
No safety concerns were observed during the study.
Next steps include testing the hydrogel in larger preclinical studies over longer periods.
Researchers also plan to see if less frequent use, such as two or three times a week, could be effective.
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Menopause
IBSA UK launches non-hormonal injectable for menopause symptoms
IBSA UK has introduced Hyaluxelle, a non-hormonal menopause treatment for vulvo-vaginal atrophy, easing vaginal dryness and pain during intercourse.
Hyaluxelle is given as deep intradermal injections to the vulvar vestibule, the area at the vaginal opening, in two sessions one month apart, followed by clinical reassessment.
IBSA UK is the UK subsidiary of Swiss pharmaceutical company IBSA.
Vulvo-vaginal atrophy is a key feature of genitourinary syndrome of menopause, a long-term condition caused by low oestrogen that affects genital, urinary and sexual health.
At least half of post-menopausal women are affected, yet many do not seek help, often assuming symptoms are part of ageing.
The condition stems from thinning and drying of vaginal and vulval tissues linked to low oestrogen, leading to symptoms such as dryness, discomfort, altered pH and pain during intercourse.
Hyaluxelle combines high and low molecular weight hyaluronic acid, a moisture-retaining substance found naturally in the body.
The company says this creates a lower-viscosity injection at what it describes as the highest concentration available in the UK, supporting tissue hydration, firmness and elasticity.
The formulation is said to rehydrate the vulvar vestibule and create conditions for restoring tissue structure through collagen and elastin production.
Clinical studies indicate Hyaluxelle improves several vulvo-vaginal symptoms, including reductions in discomfort and pain during intercourse.
Studies also report gains in sexual function domains and a positive trend in some aspects of health-related quality of life.
Histological analyses suggest increased epithelial thickness, enhanced tissue regeneration and reduced inflammatory infiltration after the procedure. In studies, the treatment was well tolerated with no reported major complications.
Joanna, a 59-year-old woman living with severe symptoms, described the personal impact of delayed diagnosis.
She said: “I lived for years with pain, UTIs, cystitis and a loss of sensation, but every visit to my GP, even a female GP, was treated as a bladder issue.
“Nobody suggested it might be linked to the menopause or joined the dots, and none of the treatments I was given helped. Without the right information or support, I became desperate for answers.
“The symptoms affected everything, what I wore, how I exercised, how I slept, but the hardest part was the impact on intimacy with my husband.
“I withdrew from our relationship because I was scared sex would hurt, and the loss of closeness was devastating, and I no longer felt like myself.
“Women deserve clear explanations and real options when their symptoms are not getting better.”
IBSA says Hyaluxelle offers clinicians an option for women whose symptoms persist despite first-line therapies, or for those who cannot receive or choose not to receive hormonal treatments.
Menopause
Study reveals gap between perimenopause expectations and experience
A study of 17,494 people has revealed a gap between perimenopause symptoms people expect and those they report, with fatigue and exhaustion far outranking hot flushes.
While 71 per cent associated perimenopause with hot flushes, those reporting perimenopause cited exhaustion (95 per cent) and fatigue (93 per cent) far more often.
Among more than 12,000 participants over age 35, the most common symptoms were fatigue (83 per cent), exhaustion (83 per cent), irritability (80 per cent), low mood (77 per cent), sleep problems (76 per cent), digestive issues (76 per cent) and anxiety (75 per cent).
Researchers at Mayo Clinic conducted the study with Flo, a women’s health application, assessing symptoms among 17,494 people from 158 countries.
First author Mary Hedges is a community internal medicine physician at Mayo Clinic in Florida.
Hedges said: “This study shines a light on how little we still understand about perimenopause and how much it affects people’s daily lives.
“At Mayo Clinic, we’re working to expand that understanding so we can improve awareness and guide care that truly meets the needs of each patient.”
The findings show fatigue, mood changes and sleep-related issues sit at the centre of many people’s experiences during perimenopause, the years leading up to the final menstrual period and the first year after it ends. This transition can start in the 30s and last several years.
When asked what they associate with perimenopause, participants most often named hot flushes (71 per cent), sleep problems (68 per cent) and weight gain (65 per cent).
The study distinguishes between exhaustion and fatigue, with exhaustion defined as a general decrease in performance, impaired memory, decreased concentration and forgetfulness, whilst fatigue refers to physical exhaustion.
Researchers noted that hormone shifts may disrupt the body’s natural rhythms and restorative sleep, while mood changes can be influenced by hormones, inflammation and diet.
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