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

NCT ID: NCT00820664

Last Updated: 2016-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

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).

Conditions

Postmenopausal Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

17β-estradiol 2.0 milligrams

Estrace 2.0 mg tablet

Group Type: ACTIVE_COMPARATOR

Comparator: Estrace 2 mg

Intervention Type: DRUG

2 mg tablets taken once daily for 28 days.

17β-estradiol 0.5 milligrams

Estrace 0.5 mg tablet

Group Type: ACTIVE_COMPARATOR

Comparator: Estrace 0.5 mg

Intervention Type: DRUG

0.5 mg tablet taken once daily for 28 days

3

Placebo

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Placebo 0 mg capsule taken once daily for 28 days

Interventions

Comparator: Estrace 0.5 mg

0.5 mg tablet taken once daily for 28 days

Intervention Type: DRUG

Comparator: Estrace 2 mg

2 mg tablets taken once daily for 28 days.

Intervention Type: DRUG

Comparator: Placebo

Placebo 0 mg capsule taken once daily for 28 days

Intervention Type: DRUG

Other Intervention Names

Estrace; Estrace

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2009_505

Identifier Type: -

Identifier Source: secondary_id

0000-122

Identifier Type: -

Identifier Source: org_study_id