OBJECTIVE: To investigate the effects of 17β-estradiol 1mg plus drospirenone 2mg (E2/DRSP) treatment on mammographic breast density in perimenopausal women. STUDY DESIGN: In this prospective study, 80 healthy perimenopausal women aged 41-49 years were enrolled and assigned to either E2/DRSP (n=40) or a control group (n=40). Mammograms were performed at baseline and after 12 months of treatment. Mammographic breast density was quantified according to the Wolfe classification. RESULTS: We demonstrated an increase in mammographic breast density in 37% (95% CI (confidence interval): 18.8-55.3%) of women treated with E2/DRSP after 12 months. The percentage of women with increased density was 0% (95% CI: 0.0-0.0%) in the control group. The difference in breast density between the E2/DRSP group and the control group was statistically very significant (p<0.001). CONCLUSIONS:E2/DRSP therapy for 12 months in perimenopausal women significantly increased mammographic breast density in comparison to a control group. Further long-term and large scale prospective studies are needed to evaluate this issue.
RCT Entities:
OBJECTIVE: To investigate the effects of 17β-estradiol 1mg plus drospirenone 2mg (E2/DRSP) treatment on mammographic breast density in perimenopausal women. STUDY DESIGN: In this prospective study, 80 healthy perimenopausal women aged 41-49 years were enrolled and assigned to either E2/DRSP (n=40) or a control group (n=40). Mammograms were performed at baseline and after 12 months of treatment. Mammographic breast density was quantified according to the Wolfe classification. RESULTS: We demonstrated an increase in mammographic breast density in 37% (95% CI (confidence interval): 18.8-55.3%) of women treated with E2/DRSP after 12 months. The percentage of women with increased density was 0% (95% CI: 0.0-0.0%) in the control group. The difference in breast density between the E2/DRSP group and the control group was statistically very significant (p<0.001). CONCLUSIONS:E2/DRSP therapy for 12 months in perimenopausal women significantly increased mammographic breast density in comparison to a control group. Further long-term and large scale prospective studies are needed to evaluate this issue.