British researchers are developing a testosterone hormone patch to help combat symptoms linked to menopause, which if successful would be a world first that could help women secure better access to a hormone that is widely available to men but is subject to fierce debate over whether it should be used to alleviate symptoms of menopause in women.
The patch is being developed to help boost the sex drive of women with symptoms of menopause, accordingtonewsreports.
Women’s natural production of testosterone drops drastically after menopause and low levels can cause issues including headaches, loss of libido, impaired focus and tiredness.
While there are a plethora of testosterone replacement therapies available to men around the world, the few available to women are in the form of creams and gels, which are tough to dose properly and can rub off on clothing, surfaces and materials.
British company Medherant, founded by David Haddleton, a chemist at England’s University of Warwick, said it plans to start clinical trials testing the patch’s effect on libido in the coming months.
If the trials are successful and the patch is approved by regulators, it could be the first and only testosterone replacement patch available to women worldwide.
Haddleton said the impact of the patch on women’s wellbeing could be “huge,” adding that they could potentially “remove needless misery from women’s daily lives.”
What We Don’t Know
Clinical trials and ushering new products through regulatory approval to market can take a very long time, often in the scale of years or even decades. It’s not clear how long trials of the patch may take, whether they will be successful or, if promising, whether they will be enough to convince regulators to approve it. Haddleton told the Guardian the patch would be introduced to the U.K. first if trials are successful. The possibility of a potential U.S. trial or rollout is not clear. Forbes has contacted Haddleton and Medherant for comment.
$3.7 million (£3 million). That’s how much Medherant said it has raised to fund trials testing the patch.
Hormone production drops in the lead-up to and following menopause, which is 12 months after a person’s last menstrual period. For those affected—a group that largely consists of cisgender women but also includes trans men, nonbinary individuals, people with variations in sex characteristics—the menopausal transition can be accompanied by symptoms like hot flashes, difficulty sleeping, irritability, depression and a loss of sex drive. It usually lasts around seven years but can last as long as 14, according to the National Institute on Aging. Hormone replacement therapy (HRT) patches are common to combat some symptoms, though they focus on replacing estrogen and progesterone.
Scientists and clinicians are divided on whether testosterone is an appropriate treatment for menopause symptoms. Evidence suggests the hormone could help alleviate many symptoms linked to menopause, particularly the lower sex drive, but data is relatively limited. Meanwhile, a plethora of testosterone replacement products are available for men—there are dozens approved in the U.S.—in forms including gels, creams and injections. Reports suggest many women are being prescribed the products approved for men “off-label” and the lack of a product formulated for women runs the risk of using too much.