No more sleepless nights in perimenopause—an open-label, randomized, parallel-group, active controlled intervention study in perimenopausal women with vasomotor symptoms and insomnia to investigate the efficacy of hormone replacement therapy and cogn

The goal is to enable evidence-based treatment decisions for affected women to close the menopausal medical care gap and improve women's quality of life. TRIAL REGISTRATION {2A, 2B}: The study has been registered at ClinicalTrials.gov (Identifier: NCT06497894) on 11 July 2024. URL: ( https://clinicaltrials.gov/ct2/show/NCT06497894 ). PROTOCOL VERSION AND TRIAL STATUS {3}: Protocol version 3.1 (30. April 2024). Recruitment has not started yet (15. August 2024). The recruitment is planned to begin on 01. November 2024, with an estimated completion date of 01. April 2026.