Lindus Health, known for running clinical trials much faster and more reliably, and Frieda Health, a Berlin‑based femtech company, have announced that their clinical trial of a digital therapy for menopause has successfully concluded. The pilot study tested Frieda’s Menova app which offers cognitive behavioural therapy to help with menopausal symptoms including hot flushes, sleep problems and psychological distress. It is the first study to assess a digital CBT‑based therapy specifically for menopause and climacteric conditions.
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Women often suffer a mix of psychological symptoms, bodily discomfort and vasomotor issues during menopause. The usual treatment for severe symptoms tends to be hormone replacement therapy but many women avoid it because of health risks such as breast cancer and stroke. CBT has already shown promise as an alternate treatment for things like hot flushes, disrupted sleep and low mood.
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Frieda Health designed the trial so that women all over Germany could join from home. The study enrolled one hundred women with natural menopause confirmed by a physician and with symptoms judged to be of clinical significance. Lindus Health handled everything from regulatory paperwork and finding participants through to data handling and analysis. The entire enrolment and screening process was done via telemedicine which made participation easier and more accessible.
Dr Anita Phung, Medical Monitor at Lindus Health, said that since half of the world’s population will go through menopause it is vital to explore treatments beyond traditional HRT and that new options should match each person’s needs. Dr Kai Schulze‑Wundling, Co‑founder and Chief Medical Officer at Frieda Health, added that their work with Lindus is a big step toward filling the gap in menopause care and that digital solutions can now join diabetes or mental health in having credible non‑drug treatment options.
The results from the Menova app showed large and clinically meaningful improvements in symptom burden compared to standard care. The improvements were statistically significant and support further development of digital CBT as a viable treatment for menopausal symptoms.
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