Digitized assessment of mammographic breast density in patients who received low-dose intrauterine levonorgestrel in continuous combination with oral estradiol valerate: a pilot study.
OBJECTIVE: To perform a pilot study of the effects on the breast by low-dose intrauterine progestogen combined with estrogen. DESIGN: A prospective pilot study. SETTING: University hospital. PATIENT(S): Twenty postmenopausal women without any previous breast disorder. INTERVENTION(S): Women were treated with a low-dose intrauterine system releasing 20 microg/24 hours of levonorgestrel in continuous combination with 2 mg of oral E2 valerate. The effects on mammographic breast density, breast cell proliferation, and hormonal levels were followed for 18 months. MAIN OUTCOME MEASURE(S): Change in mammographic breast density and breast cell proliferation. Correlations with levels of hormones, growth factors, and binding proteins. RESULT(S): Three women showed an apparent increase in density. For the remaining 17 women the changes were only a few percent. Digitized assessment of density showed strong correlations with visual classification scales (rs = 0.96-0.97). There was no increase in proliferation as expressed by the percentage of MIB-1-positive breast cells in fine-needle aspiration biopsies. Increase in breast density displayed a positive correlation with patients age (rs = 0.52) and an inverse relationship with levels of E2 (rs = -0.50) and free T (rs = -0.50). CONCLUSION(S): Low-dose intrauterine administration progestogen may develop into an attractive alternative for hormonal therapy in postmenopausal women as endometrial protection may be achieved at very low systemic levels.