Study Comparing 17B Estradiol/TMG CC 1mg Vs. Tibolone In Postmenopausal Women

A Prospective, Randomized, Open Label Study To Compare The Efficacy, Safety And Tolerability Of 17-B Estradiol/Trimegestone CC 1 Mg (Totelle) And Tibolone (Livial) In Postmenopausal Women.

This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).

Inclusion Criteria:

• Generally healthy postmenopausal women
• Last natural (without exogenous hormone therapy) menstrual cycle completed at least 12 consecutive months prior to screening and without any other kind of gynecological bleeding during this same period
• At least 1 year of natural occurring amenorrhea

Exclusion Criteria:

• Known or suspected estrogen-dependent neoplasia
• Endometrial hyperplasia
• Any malignancy with the exception of a history of basal cell carcinoma of the skin