Lindus Health and Berlin-based femtech startup Frieda Health have successfully completed the first clinical trial evaluating a digital therapeutic utilizing cognitive behavioral therapy (CBT) for menopause symptom management. The open-label pilot study demonstrated that the Frieda Menova app produced large, clinically meaningful and statistically significant reductions in menopausal symptom burden compared to standard of care.
Novel Digital Approach Addresses Treatment Gap
The study represents a significant milestone in women's health, addressing a critical care gap for the approximately half of the global population that will experience menopause. The Frieda Menova app integrates CBT to target vasomotor disturbances, sleep disruption, and psychological distress—symptoms that significantly impact quality of life during menopause and climacteric states.
"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."
Innovative Remote Trial Design
The study enrolled 100 participants with physician-confirmed natural menopause diagnosis and clinically significant symptoms across Germany. Frieda Health leveraged an innovative trial design that allowed menopausal women to participate remotely, expanding access beyond traditional study site centers. Screening and enrollment were conducted via telemedicine visits, making participation more efficient and accessible.
Lindus Health provided comprehensive trial oversight, including regulatory submissions, participant recruitment through targeted social media campaigns, monitoring, data management, and statistical analysis. The company served as the sole virtual site, deploying novel internal central recruitment capabilities to identify and engage participants.
Alternative to Hormone Replacement Therapy
The digital therapeutic addresses a significant unmet need in menopause management. While hormone replacement therapy (HRT) remains the current standard-of-care for severe menopause symptoms, many women choose not to receive HRT due to increased health risks such as breast cancer and stroke. CBT has previously proven effective as an alternative treatment option for improving menopause symptoms including hot flushes, sleep disturbances, and depressed mood.
"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."
Clinical Evidence Foundation
Frieda Health's Menova therapy builds on prior trials demonstrating that cognitive-behavioral approaches—delivered in person or digitally—can meaningfully lessen the impact of hot flushes and night sweats while improving quality of life. The Frieda Health platform is CE-marked (EU MDR Class I) and systematically assesses symptoms, delivers evidence-based guidance grounded in CBT and lifestyle medicine, and connects users to physician-supervised care when needed.
The successful completion of this pilot study reinforces the promise of digital CBT for menopause management and provides guidance for further development of digital therapeutics in women's health. Frieda Health plans to expand into additional high-need topics in women's health and explicitly link programs to female longevity, helping women extend their healthy years through prevention, risk-reduction, and sustained self-management starting at midlife.
