Study Evaluating Totelle® in Menopausal Symptoms and Sexual Function

An Open Assessment of the Effect of Low-Dose Totelle® 1 mg on Menopausal Symptoms, Sexual Function and Quality of Life

To evaluate the tolerability, bleeding patterns and acceptability of Totelle® 1mg administered to a population of Brazilian women in a continuous combined regime for hormone replacement therapy.

Inclusion Criteria:

• Intact uterus
• Generally health postmenopausal women 45 to 60 years of age, inclusive
• Sexually active
• No hormone replacement therapy within the 90 days immediately prior to the screening evaluation.

Exclusion Criteria:

• Known or suspect estrogen-dependent neoplasia
• Known hypersensitivity to estrogens, progestins, or other ingredients of Totelle
• Use of any estrogen, progestin, androgen containing medications or tibolone within 12 weeks before screening.