A Clinical Study to Evaluate the Effects of Estrogen in Healthy Postmenopausal Women - Full Text View

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:	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:

Drug Information available for: Estradiol Estradiol 3-benzoate Polyestradiol phosphate Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Further study details as provided by Merck:

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

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:	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 3-benzoate
Estradiol 17 beta-cypionate
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 February 09, 2012