- 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
- 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.