Wearable devices in hormonal clinical trials: the key to unlocking major progress in female health?

For decades, research into the hormonal impacts on female health has too often been overlooked or side-lined by a pharmaceutical industry where senior female representation hasn't always been prevalent.

A lack of funding has seen comparatively few clinical trials supported through to completion, leaving women battling to get the treatment and understanding their conditions demand.

Now, though, a new generation of MedTech founders and entrepreneurs are hoping to finally overcome the barriers preventing progress in the understanding and treatment of issues including fertility, PCOS, breast cancer, and menopause.

An industry ready to step forward

Samantha Muse-Miller, business development manager (North America) at Woodley Trial Solutions, attended OCT Southern California in September 2024. “A big discussion point was about getting earlier diagnoses in female health,” she says. “Often, a lot of the health issues that are affected by your hormones aren’t discovered until a woman is in her twenties or thirties and trying to get pregnant.”

She adds: “The other issue is trying to increase funding for clinical trials focusing on women’s health. One of the major reasons there aren’t many studies is that only a small percentage of leadership roles in pharma companies are held by women, so the importance and potential impact of these trials can often get overlooked.”

Bringing wearables to the forefront of research efforts

Most clinical trials centred on hormonal data currently rely on blood tests, urine strips, or saliva tests. But Kerli Luks, founder of Muun Health, is preparing to launch a new wearable device targeted specifically at women’s health.

“We’re still at an early stage,” says Kerli, “but our aim is to have a device similar to continuous glucose monitors that focuses entirely on female hormones. Our intention is for our device to look at a range of issues, including PCOS, pregnancy monitoring, hormonal imbalances, IVF monitoring, and menopause.

“Female hormones fluctuate significantly. We’re trying to gather more information about female hormone levels, what affects our hormones, and how our hormones affect our everyday life.”

For Kerli, the mission is driven by her personal experience. She says: “I’m a medical doctor by training and I started this because so many women were coming to my clinical practice with hormonal issues.

“It was every second or third female patient. But even with gold standard blood tests processed through a lab, it’s still so difficult to interpret the data because every woman’s base levels are so different.

“With a continuous monitoring device, we can hopefully begin to understand what is specific to each woman. In turn, we can then start to diagnose issues better and earlier than before and treat them more effectively.”

Expert clinical trial support with wearable devices

Some progress is being made with female-health-focused clinical trials. In December 2023, the European Commission approved fezolinetant as a daily treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause*. But there is still much more to do. 

In recent years, Woodley Trial Solutions has seen a significant increase in the number of clinical trials incorporating wearable and connected devices into their protocols. Through continuous monitoring and fast data gathering, researchers and sponsors are now able to understand their patient population more quickly and accurately – and, where needed, we are keen to demonstrate our commitment to women’s health by supporting future trials with expert advice, guidance, and product supply.

Our experience with supporting decentralised clinical trials gives us a unique perspective on the key attributes needed for trial success. If you’re a CRO or sponsor actively preparing for a clinical trial in female health, contact our friendly team for support and assistance every step of the way.