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Objectives To compare the incidence of increased breast density and tenderness in postmenopausal women associated with transdermal (Estalis/Combipatch ® , Novartis, Basel, Switzerland) and oral (Kliogest ® , Schering AG, Berlin, Germany) hormone replacement therapy (HRT). Methods A total of 202 postmenopausal women were randomized to transdermal or oral HRT. Mammograms obtained at study entry and after 1 year of treatment were assessed for percent breast density by means of the digital segmentation and thresholding technique. Breast tenderness was assessed at each study visit. Results The mean breast density by ANCOVA after adjusting for screening value at study end was significantly lower for women using Estalis ® (38.4%, standard error 0.9%) compared with Kliogest ® (46.9%, standard error 1.5%) ( p < 0.0001). Significantly fewer women using transdermal HRT had an increase in mammographic breast density or breast tenderness compared to oral HRT. Of the women using transdermal HRT, 39.1% had no change in breast density compared to 15.7% for women using oral HRT. Only 4% of women using transdermal HRT had a marked increase in density (?>?25%) compared to 15.7% of women using oral HRT. Overall, 36.0% of patients in the transdermal group reported breast tenderness at some point during the 1-year study, compared with 57.6% in the oral HRT group ( p ?=?0.0002). Conclusion Transdermal HRT use is associated with a significantly lower incidence of increased mammographic breast density and breast tenderness compared with oral HRT. [ABSTRACT FROM AUTHOR]