A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women

Inclusion criteria

• Patient is a healthy postmenopausal woman less than or equal to 65 years of age with onset of menopause less than or equal to 10 years prior to prestudy visit 1
• Patient has a uterus and no history of uterine bleeding in the past 3 months
• Patient has not had a previous endometrial biopsy within the last 4 weeks
• Patient has had a normal mammogram within the last 11 months
• Patient has had a normal pap-smear within the past 3 years prior to screening
• Patient has had a normal transvaginal ultrasound of the endometrium
• Patient is willing to avoid strenuous physical activity such as strenuous or unaccustomed weight lifting, running, bicycling, etc for the duration of the study
• Patient agrees to not consume grapefruit products beginning approximately 2 weeks prior to the first dose of study drug and throughout the study
• Patient agrees to limit daily consumption of alcohol. During the study, daily alcohol consumption should not be more than 2 glasses
• Patient agrees to limit daily consumption of caffeine. During the study, daily caffeine consumption should not exceed 3 cups of coffee
• Patient is a non-smoker

Exclusion criteria

• Patient is mentally or legally incapacitated
• Patient has a history of any first degree relatives with breast or endometrial cancer
• Patient has a history of multiple and/or severe allergies to prescription or non-prescription drugs or food
• Patient has used any type of estrogen or progesterone preparation unless followed by appropriate wash-out periods
• Patient has had surgery, donated approximately 500 mL of blood or has participated in another investigational study within the last 4 weeks
• Patient has a history of deep vein thromboses, coronary artery disease, heart attack or stroke
• Patient is a current user of illegal drugs
• Patient has a history of hypersensitivity to estrogen products
• Patient is unable to refrain from using anti-coagulants