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A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
This study has been completed.
First Received: January 8, 2009   Last Updated: August 4, 2009   History of Changes
Sponsor: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00820664
  Purpose

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).


Condition Intervention Phase
Postmenopausal Symptoms
Drug: Comparator: Estrace 0.5 mg
Drug: Comparator: Estrace 2 mg
Drug: Comparator: Placebo
Phase I

Study Type: Interventional
Study Design: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women

Resource links provided by NLM:


Further study details as provided by Merck:

Primary Outcome Measures:
  • 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. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean gene expression intensity after 4 weeks of either 0.5 or 2 mg Estrace compared to placebo. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Estrace 0.5 mg tablet
Drug: Comparator: Estrace 0.5 mg
0.5 mg tablet taken once daily for 28 days
2: Active Comparator
Estrace 2 mg tablet
Drug: Comparator: Estrace 2 mg
2 mg tablets taken once daily for 28 days.
3: Placebo Comparator
Placebo
Drug: Comparator: Placebo
Placebo 0 mg capsule taken once daily for 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820664

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers: 2009_505, 122
Study First Received: January 8, 2009
Last Updated: August 4, 2009
ClinicalTrials.gov Identifier: NCT00820664     History of Changes
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Estrogens
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions
Estradiol

ClinicalTrials.gov processed this record on February 08, 2010