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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00820664
Recruitment Status : Completed
First Posted : January 12, 2009
Results First Posted : May 7, 2010
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE January 8, 2009
First Posted Date  ICMJE January 12, 2009
Results First Submitted Date  ICMJE April 13, 2010
Results First Posted Date  ICMJE May 7, 2010
Last Update Posted Date January 22, 2016
Study Start Date  ICMJE December 2008
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2010)
Immunohistochemistry (IHC) Proliferative Effects Measurement [ Time Frame: 4 weeks ]
Ratio of the total number of positively stained cell nuclei to the total number of cell nuclei. Proliferating endometrial cells express the Ki-67 antigen. The ratio was converted to a percent proliferating cells by taking the number of Ki-67 positive stained nuclei in a given field and dividing by the total number of nuclei in that field and multiplying by 100. At least 5 high power fields were scored in this manner and an aggregate percent Ki-67 positive cells was reported. Square root transformation was taken to make it approximately normally distributed for an ANOVA model to apply.
Original Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
Mean Gene Expression Intensity After 4 Weeks of Either 0.5 or 2 mg Estrace Compared to Placebo. [ Time Frame: 4 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women
Official Title  ICMJE A Randomized Clinical Trial to Evaluate the Effects of Estrogen on Uterine Endometrium in Healthy Postmenopausal Women
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Condition  ICMJE Postmenopausal Symptoms
Intervention  ICMJE
  • Drug: Comparator: Estrace 0.5 mg
    0.5 mg tablet taken once daily for 28 days
    Other Name: Estrace
  • Drug: Comparator: Estrace 2 mg
    2 mg tablets taken once daily for 28 days.
    Other Name: Estrace
  • Drug: Comparator: Placebo
    Placebo 0 mg capsule taken once daily for 28 days
Study Arms  ICMJE
  • Active Comparator: 17β-estradiol 2.0 milligrams
    Estrace 2.0 mg tablet
    Intervention: Drug: Comparator: Estrace 2 mg
  • Active Comparator: 17β-estradiol 0.5 milligrams
    Estrace 0.5 mg tablet
    Intervention: Drug: Comparator: Estrace 0.5 mg
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Comparator: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2010)
29
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)
24
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00820664
Other Study ID Numbers  ICMJE 0000-122
2009_505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP