OBJECTIVEThis study aimed to develop and validate the Menopause-Specific Health Literacy Scale (Men-HLS) for middle-aged women aged 45-64 years, utilizing an Item Response Theory (IRT) framework and traditional factor analysis.METHODSBased on the four subdomains (access, understand, appraise, and apply) of the integrated health literacy conceptual model proposed by the European Health Literacy Consortium, we developed 73 preliminary items, combining self-reported (subjective) and performance-based (objective) measures. Content validity was assessed by an expert panel (n = 14) and face validity was evaluated by the target population (n = 15). Validity and reliability were evaluated using exploratory factor analysis (EFA), confirmatory factor analysis (CFA), internal consistency, and item analysis based on classical test theory and IRT.RESULTSThe scale was refined to 45 items following content and face validity assessments and reduced to 35 items through classical test theory-based item analysis and inter-item correlation. EFA removed seven cross-loaded items, resulting in three distinct factors: accessing (ACS), appraising (APR), and utilizing (UTL). The IRT analysis demonstrated high item discrimination, with four items in the UTL subdomain showing moderate discrimination. CFA confirmed a good model fit. The final Men-HLS comprised 28 items (6 for ACS, 9 for APR, and 13 for UTL) and achieved a Cronbach's alpha of 0.91.CONCLUSIONSThe Men-HLS is a valid and reliable instrument for identifying health literacy challenges in middle-aged women. Further research is needed to establish its predictive validity through longitudinal data and confirm its measurement invariance across diverse sociodemographic groups.PRACTICE IMPLICATIONSThe Men-HLS provides healthcare professionals with a practical tool for assessing the health literacy levels required to manage menopausal symptoms and chronic conditions, facilitating the development of targeted educational resources and interventions for improved health management.