This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
135
1/5 mg/day for 12 cycles of 28 days
2,5 mg/day for 12 cycles of 28 days
Site 8
Ancona, Italy
Site 15
Cagliari, Italy
Site 4
Catania, Italy
Site 9
Florence, Italy
IGF1 values after 12 cycles of 28 days
Time frame: 1 year
after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern
Time frame: 1 year
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Site 10
Milan, Italy
Site 11
Milan, Italy
Sit 14
Modena, Italy
Site 6
Roma, Italy
Site 1
Torino, Italy
Site 2
Torino, Italy
...and 1 more locations