Study to Compare the Effect of Hormone Replacement Therapy (HRT) on Breast and Cardiovascular Metabolic Markers in Postmenopausal Women

A Twelve 28-Day Cycles, Multicenter, Prospective, Randomized, Open, Blinded Endpoint, Parallel Group Study Comparing the Effect on Breast and Cardiovascular Metabolic Markers of Continuously Combined 17β-Estradiol/Dydrogesterone and Tibolone in Postmenopausal Women.

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.

Inclusion Criteria:

• Natural or surgical postmenopausal amenorrhea since ≥ 12 months,
• non hysterectomized women, complaining of at least 14 hot flushes per week

Exclusion Criteria:

• Known, suspected or history of breast cancer or hormone-dependent neoplasia,
• undiagnosed genital bleeding,
• venous or arterial history or presence of thromboembolism,
• cerebrovascular disease