Sidekick Health expands to menopause - begins clinical study for prescription digital therapeutic
12-week clinical study in Germany
Digital health company Sidekick Health has announced that it is expanding into menopause and will launch a clinical study for its new prescription digital therapeutic for menopause.
MENO! app is designed to address the unmet needs of women experiencing menopause and it will undergo a 12-week clinical study in Germany to further validate its impact on menopause symptom relief. By validating as a digital therapeutic, Sidekick Health can ensure the app can deliver real, measurable outcomes over and above user engagement.
MENO! App is a CE-marked digital therapeutic for menopause, offering evidence-based cognitive behavioral therapy (CBT) specifically designed to reduce symptom burden. Unlike traditional menopause treatments that focus solely on Menopause Hormone Therapy (MHT), MENO! App provides a non-hormonal, accessible alternative to help women manage their symptoms holistically. The app integrates behavioral interventions with lifestyle support, empowering users with self-guided tools tailored to their individual health needs.
Menopause, a universal experience, is an underserved area of women’s health — one in four women suffer from severe symptoms such as hot flashes, sleep disturbances, and mood changes that significantly impact their quality of life and work. Yet treatment options remain limited and often inaccessible.
"We invest in innovative digital health solutions that address the individual needs of women at various stages of life," said Prof. Dr. Pia Wülfing, chief clinical officer for Sidekick Health Group and a licensed OB/GYN.
"Our focus lies in combining technology with medical expertise to improve healthcare outcomes."
Advancing women's health through research
Sidekick has launched a decentralized, randomized-controlled clinical study in Germany, where Sidekick Health Group already has two PDTs listed in Germany's regulated nationwide DiGA (Digitale Gesundheitsandwendungen) formulary, PINK! Coach and zanadio. The study will evaluate the effectiveness of MENO! App in a 12-week study that will enroll women aged 40-65 experiencing bothersome menopausal symptoms.
Participants will be randomized into two groups—one using the MENO! App and the other receiving standard care. After completion, the control group will also gain access to the app, ensuring all participants benefit from this innovation.
With over 100,000 prescriptions issued and 16,000 healthcare providers prescribing its PDTs, Sidekick Health Group is a leading provider of prescription digital therapeutics in Germany. The expansion into menopause care represents a significant step in delivering comprehensive, science-backed solutions for women at every stage of life.
An holistic approach to women's health
Sidekick Health Group has already demonstrated success in digital health solutions for maternity care, supporting women from pregnancy through postpartum recovery. Its maternity program is designed to improve full-term pregnancy rates, reduce NICU admissions, and help stabilize maternal blood sugar and blood pressure.