Lindus Health, the “anti-CRO” running radically faster, more reliable clinical trials for life science pioneers, and Berlin-based femtech startup Frieda Health have announced the successful completion of their clinical trial for a digital therapeutic to treat symptoms of menopausal and climacteric states. This open-label pilot study evaluated the Frieda Menova app—Frieda Health’s proprietary digital therapeutic that integrates cognitive behavioral therapy (CBT)—for its effectiveness in alleviating menopausal symptoms, including vasomotor disturbances, sleep disruption, and psychological distress. This was the first clinical trial to evaluate a digital therapeutic utilizing CBT for the treatment of menopause symptoms.
Women experience a wide range of psychological, somatic, and vasomotor symptoms during menopause. The current standard-of-care to treat severe menopause symptoms is hormone replacement therapy (HRT), however, many women choose not to receive HRT due to increased health risks such as breast cancer and stroke. CBT has proven to be an effective alternative treatment option in improving menopause symptoms like hot flushes, sleep disturbances, and depressed mood.
Frieda Health leveraged an innovative novel trial design that allowed menopausal women to participate in the study remotely across Germany, expanding access to the study typically reserved for study site centers.
The study enrolled 100 participants with a physician-confirmed natural menopause diagnosis and clinically significant symptoms. Lindus Health provided end-to-end oversight of the trial—covering regulatory submissions, participant recruitment, monitoring, data management, and statistical analysis. Serving as the sole virtual site, Lindus Health also deployed its novel internal central recruitment capabilities to identify and engage participants through targeted social media campaigns. Screening and enrollment were conducted via telemedicine visits, making participation more efficient and accessible.
“Half the global population will experience menopause and it is important to understand this stage of life,” said Dr. Anita Phung, Medical Monitor at Lindus Health. “We’re excited to see new interventions for menopause on the horizon that offer alternatives to traditional HRT, allowing treatment approaches to be tailored to individual preferences. We can’t wait to see the results of the trial.”
“Our work with Lindus marks major development in closing the care gap for women with menopause,” said Dr. Kai Schulze-Wundling, Co-founder and Chief Medical Officer at Frieda Health. “There are credible digital solutions to managing diabetes, mental health conditions, and numerous other common indications—it’s time we add menopause to the list.”
The Frieda Menova app produced large, clinically meaningful and statistically significant reductions in menopausal symptom burden compared to standard of care, reinforcing the promise of digital CBT for menopause and guiding further development.
