Clinical trial NCT00820664: A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Official title: A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Symptoms
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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

Primary outcomes:
measure: Immunohistochemistry (IHC) Proliferative Effects Measurement
timeFrame: 4 weeks
Secondary outcomes:
measure: Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo.
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: