A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Condition: Postmenopausal Symptoms
Intervention: Comparator: Estrace 0.5 mg; Comparator: Estrace 2 mg; Comparator: Placebo
Intervention description: 0.5 mg tablet taken once daily for 28 days; 2 mg tablets taken once daily for 28 days.; Placebo 0 mg capsule taken once daily for 28 days
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to examine the effect of two different dose levels of estrogen
      or placebo in healthy postmenopausal women by measuring the changes in hormone levels and
      examining the changes in the uterine lining (endometrium).
    

Eligibility criteria:

        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