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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00820664
First received: January 8, 2009
Last updated: May 10, 2010
Last verified: May 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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 Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Immunohistochemistry (IHC) Proliferative Effects Measurement [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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.


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: 29
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
Active Comparator: 17β-estradiol 2.0 milligrams
Estrace 2.0 mg tablet
Drug: Comparator: Estrace 2 mg
2 mg tablets taken once daily for 28 days.
Other Name: Estrace
Active Comparator: 17β-estradiol 0.5 milligrams
Estrace 0.5 mg tablet
Drug: Comparator: Estrace 0.5 mg
0.5 mg tablet taken once daily for 28 days
Other Name: Estrace
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820664

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00820664     History of Changes
Other Study ID Numbers: 2009_505, 122
Study First Received: January 8, 2009
Results First Received: April 13, 2010
Last Updated: May 10, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 28, 2014