Eligibility criteria
Condition
Hot Flashes, Sleep Disorders
Sex
Female
Age
45-60 years
Inclusion criteria
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- 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
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- 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.