Lindus Health and Frieda Health Conclude Successful Clinical Trial for Menopausal Treatment

Lindus Health and Frieda Health: A New Era in Menopausal Treatment

Lindus Health and Berlin-based Frieda Health have proudly announced the successful completion of their innovative clinical trial involving a digital therapeutic aimed at alleviating menopausal symptoms. This pioneering study focused on evaluating the Frieda Menova app, which incorporates cognitive behavioral therapy (CBT) to help women undergoing this transitional stage of life.

The Challenge of Menopause

Menopause brings a multitude of challenges, with women experiencing various psychological and physiological symptoms such as hot flushes, sleep disturbances, and mood changes. Traditionally, hormone replacement therapy (HRT) has been the go-to option for relieving severe menopause symptoms. However, many women forgo HRT due to the associated health risks, which can include conditions like breast cancer or stroke.

Recognizing the need for safer alternatives, the study set forth to explore the efficacy of digital cognitive behavioral therapy — a method proven effective in other health domains but not widely applied to menopausal symptom treatment until now.

The Clinical Trial Design

Conducted as an open-label pilot study, this trial enrolled 100 women who had a physician-confirmed diagnosis of natural menopause, paired with clinically significant symptoms. Unique to this study, participants were able to engage remotely, which broadened accessibility and allowed a more extensive reach across Germany. This innovative design marks a significant shift in how clinical trials can adapt to modern needs, significantly easing entry for participants.

Lindus Health managed every facet of the trial from regulatory compliance to participant recruitment, utilizing a cutting-edge software platform for real-time data management and statistical analysis. By employing telemedicine for screening and enrollment, the process was not only streamlined but also more inclusive for those who otherwise might struggle to participate.

Insights from the Research

Dr. Anita Phung, Medical Monitor at Lindus Health, expressed the vast importance of understanding menopause as a natural life stage affecting half the global population. She emphasized the excitement around the development of new interventions that can cater to individual preferences and needs, moving away from traditional treatments that might not serve every woman’s interests.

The results from the Frieda Menova app showcased promising outcomes, with statistically significant reductions in the burden of menopausal symptoms compared to the standard of care. This not only validates the potential of digital CBT in this realm but also sets a new precedent for future research.

Dr. Kai Schulze-Wundling, the co-founder of Frieda Health, highlighted their commitment to addressing the care gap for menopausal women and pushing towards credible digital health solutions for this widespread issue. The successful use of the Menova therapy app positions it as a significant advance in women’s healthcare.

Future Directions

With the completion of this clinical trial, both Lindus Health and Frieda Health aim to expand upon these findings, exploring new domains in women’s health and focusing on issues related to longevity. Recognizing the importance of continual support from midlife through later years, Frieda Health plans to intersect their work in menopause with other critical health discussions around female longevity and wellness.

As both companies continue to challenge conventional healthcare barriers, they pave the way for innovative treatments that empower women in every stage of life. This trial marks only the beginning of what promises to be an exciting journey towards more personalized, effective healthcare solutions.