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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| 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 |
|
Estrogens Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Hormones Pharmacologic Actions Estradiol |