A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Information source: Merck
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postmenopausal Symptoms
Intervention: Comparator: Estrace 0.5 mg (Drug); Comparator: Estrace 2 mg (Drug); Comparator: Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
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).
Clinical Details
Official title: A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women
Study design: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: To examine the proliferative effects on the uterine endometrial tissue as measured by IHC after 4 weeks of either 0.5 or 2 mg Estrace compared to placebo.
Secondary outcome: Mean gene expression intensity after 4 weeks of either 0.5 or 2 mg Estrace compared to placebo.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Female.
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
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Miramar, Florida 33025, United States; Recruiting
Additional Information
Starting date: January 2009
Ending date: May 2009
Last updated: January 14, 2009
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